RECENT MAJOR CHANGES SECTION

Highlight: Warnings and Precautions (5.7) 11/2018

RECENT MAJOR CHANGES

Warnings and Precautions (5.7) 11/2018

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INDICATIONS & USAGE SECTION

Highlight: Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. (1)

1 INDICATIONS AND USAGE

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults.

DOSAGE & ADMINISTRATION SECTION

Highlight: Important Administration Instructions:

• Two doses of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are required for a complete preparation for colonoscopy: the first dose the evening before the colonoscopy and the second dose on the morning of the colonoscopy. (2.1 )
• Do not take other laxatives, particularly additional sodium phosphate- based purgative or enema products. (2.1,7.3 )
• Do not take oral medications within 1 hour before or after starting each dose. (2.1 , 7.2 )

Dosage Regimen (2.2)

The recommended adult dosage is 32 tablets taken orally with a total of 2 quarts of clear liquids in the following manner:

• Evening before colonoscopy: 4 tablets with 8 ounces of clear liquids every 15 minutes for a total of 20 tablets.
• Next morning: 4 tablets with 8 ounces of clear liquids every 15 minutes for a total of 12 tablets.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

• Correct fluid and electrolyte abnormalities before treatment with Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets[see Warnings and Precautions (5.1)] .
• Clear liquids must be consumed before, during and after taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets [see Dosage and Administration (2.1), Warnings and Precautions (5.1)] .
• Do not administer Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets within 7 days of a previous use.
• Two doses of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are required for a complete preparation for colonoscopy: the first dose the evening before the colonoscopy and the second dose on the morning of the colonoscopy [see Dosage and Administration (2.2)].
• Consume only clear liquids (no solid food) from the start of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets treatment until after the colonoscopy.
• Do not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material.
• Do not take other laxatives while taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, particularly additional sodium phosphate-based purgative or enema products [see Drug Interactions (7.3)] .
• Do not take oral medications within 1 hour before or after starting each dose of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets[see Drug Interactions (7.2)] .

2.2 Dosage Regimen

Instruct adult patients that on the day before their colonoscopy, they can consume a light breakfast consisting of clear soup and/or plain yogurt (no solid foods) before noon, followed by only clear liquids until after the colonoscopy.

The recommended dose of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets for colon cleansing for adult patients is 32 tablets (48 grams of sodium phosphate) taken orally with a total of 2 quarts of clear liquids in the following manner:

The evening before the colonoscopy: Take 4 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets with 8 ounces of clear liquids every 15 minutes for a total of 20 tablets.

On the day of the colonoscopy starting 3 to 5 hours before the procedure: Take 4 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets with 8 ounces of clear liquids every 15 minutes for a total of 12 tablets.

DOSAGE FORMS & STRENGTHS SECTION

Highlight: Tablets: 1.5 g of sodium phosphate (3) (3)

3 DOSAGE FORMS AND STRENGTHS

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are supplied as white to off-white uncoated tablet, modified oval shaped, biconvex, bisect on one side and plain on the other. Debossed "N" on the left side of the bisect and "03" on the right side of the bisect. Each Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets contains 1.102 grams of Monobasic Sodium Phosphate, USP and 0.398 grams of Dibasic Sodium Phosphate, USP for a total of 1.5 grams of sodium phosphate per tablet. Inert ingredients include polyethylene glycol 8000, NF; and magnesium stearate, NF.

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CONTRAINDICATIONS SECTION

Highlight: * Biopsy-proven acute phosphate nephropathy (4, 5.1 )

• Gastrointestinal (GI) obstruction (4, 5.7 )
• Gastric bypass or stapling surgery (4 )
• Bowel perforation (4 )
• Toxic colitis (4)
• Toxic megacolon (4 )
• Hypersensitivity to sodium phosphate salts or any components of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets (4, 5.7 )

4 CONTRAINDICATIONS

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are contraindicated in the following conditions:

• History of acute phosphate nephropathy [see Warnings and Precautions (5.1)]
• Gastrointestinal (GI) obstruction [see Warnings and Precautions (5.7)]
• Gastric bypass or stapling surgery
• Bowel perforation
• Toxic colitis
• Toxic megacolon
• Hypersensitivity to sodium phosphate salts or any component of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets[see Warnings and Precautions (5.7)].

BOXED WARNING SECTION

BOXED WARNING

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ADVERSE REACTIONS SECTION

Highlight: Most common adverse reactions (≥3%) are: bloating, nausea, abdominal pain, and vomiting. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals Inc. at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6 ADVERSE REACTIONS

The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling:

• Renal Disease, Acute Phosphate Nephropathy, and Electrolyte Disorders [see Warnings and Precautions (5.1)]
• Cardiac Arrhythmias [see Warnings and Precautions (5.2)]
• Seizures [see Warnings and Precautions (5.3)]
• Use in Patients with Significant Gastrointestinal Disease [see Warnings and Precautions (5.4)]
• Colonic Mucosal Ulceration and Inflammatory Bowel Disease [see Warnings and Precautions (5.5)]
• Aspiration [see Warnings and Precautions (5.6)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.7)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets was evaluated in two randomized, investigator-blinded, active controlled trials in 931 adult patients undergoing elective colonoscopy. The mean age of the study population was 60 years (range 20 to 89 years), 88% of patients were Caucasian and 55% were female [see Clinical Studies (14)].

Table 1shows the most common adverse reactions reported in greater than 3% of patients by treatment group in Study 1 [see Clinical Studies (14)]. Since diarrhea was considered as a part of the efficacy of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, diarrhea was not defined as an adverse event in this clinical trial.

Electrolyte Abnormalities in Study 1

Hyperphosphatemia

A total of, 96%, 96%, and 93% of patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, respectively, developed hyperphosphatemia (defined as phosphate level > 5.1 mg/dL) on the day of the colonoscopy. In this study, patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets had baseline mean phosphate levels of 3.5, 3.5, and 3.6 mg/dL and subsequently developed mean phosphate levels of 7.6, 7.9, and 7.1 mg/dL, respectively, on the day of the colonoscopy.

Hyperkalemia

A total of 20%, 22%, and 18% of patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, respectively, developed hypokalemia (defined as a potassium level < 3.4 mEq/L) on the day of the colonoscopy. In this study, patients who took 60 grams of oral sodium phosphate, 60 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, and 48 grams of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets all had baseline potassium levels of about 4.3 mEq/L and then developed a mean potassium level of 3.7 mEq/L on the day of the colonoscopy.

Several patients on all three sodium phosphate regimens developed hypocalcemia and hypernatremia that did not require treatment.

The Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 60-gram dosage regimen was associated with an increased risk of adverse reactions compared to the 48- gram dosage regimen and a similar overall response rate [see Clinical Studies (14)]. Therefore, the Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 60-gram dosage is not a recommended regimen [see Dosage and Administration (2.2)].

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity reactions: anaphylaxis, angioedema (swelling of the lips, tongue and face), rash, pruritus, urticaria, throat tightness, bronchospasm, dyspnea, pharyngeal edema, dysphagia, and paresthesia.

Cardiovascular: Arrhythmias

Nervous system: Seizures

Renal: Renal impairment, increased blood urea nitrogen (BUN), increased creatinine, acute renal failure, acute phosphate nephropathy, nephrocalcinosis, and renal tubular necrosis.

CLINICAL STUDIES SECTION

14 CLINICAL STUDIES

The colon cleansing efficacy and safety of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets was evaluated in a randomized, investigator- blinded, actively controlled, multicenter, U.S. trial in patients scheduled to have an elective colonoscopy (Study 1).

In Study 1, patients were randomized into one of the following three sodium phosphate treatment groups:

• An oral tablet formulation of sodium phosphate containing 60 grams of sodium phosphate given in split doses (30 grams in the evening before the colonoscopy and 30 grams on the next day) with at least 3.6 quarts of clear liquids;
• Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets containing 60 grams of sodium phosphate given in split doses (30 grams in the evening before the colonoscopy and 30 grams on the next day) with 2.5 quarts of clear liquids; and
• Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets containing 48 grams of sodium phosphate (30 grams in the evening before the colonoscopy and 18 grams on the next day) with 2 quarts of clear liquids.

Patients were instructed to eat a light breakfast before noon on the day prior to the colonoscopy and then were told to drink only clear liquids after noon on the day prior to the colonoscopy.

The primary efficacy endpoint was the overall colon cleansing response rate in the 4-point Colonic Contents Scale. Response was defined as a rating of "excellent" or "good" on the 4-point scale as determined by the blinded colonoscopist. This trial was designed to assess the non-inferiority of the two Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets groups compared to the active control group.

The efficacy analysis included 704 adult patients who had an elective colonoscopy. Patients ranged in age from 21 to 89 years old (mean age 56 years old) with 55% female and 45% male patients. Race was distributed as follows: 87% Caucasian, 10% African American, and 3% other race. The Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 60-gram and 48-gram treatment groups demonstrated non-inferiority compared to the active control. See Table 2for the results.

The Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 60-gram dosage regimen had a similar overall response rate as the 48-gram dosage regimen and was associated with an increased risk of adverse reactions [see Adverse Reactions (6.1)]. Therefore, the Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets 60-gram dosage is not a recommended regimen [see Dosage and Administration (2.2)].

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PATIENT MEDICATION INFORMATION SECTION

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Instruct patients:

• On the importance of taking the recommended fluid regimen. Advise them to hydrate adequately with clear liquids before, during, and after the use of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets [see Dosage and Administration (2.1), Warnings and Precautions (5.1)] . Examples of clear liquids can be found in the Medication Guide.
• Two doses of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are required for a complete preparation for colonoscopy.
• Do not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material.
• Not to take other laxatives or enemas made with sodium phosphate while they are taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets [see Drug Interactions (7.3)] .
• Not to take oral medications within one hour before or after starting each dose of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets [see Drug Interactions (7.2)] .
• To contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets or if they experience cardiac arrhythmias or seizures [see Warnings and Precautions (5.1,5.2,5.3)].
• To seek immediate medical care should signs and symptoms of a hypersensitivity reaction occur [see Warnings and Precautions (5.7)] .

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

Manufactured for:

Lupin Pharmaceuticals Inc.

Baltimore, MD 21202

SAP Code: 265501

Iss. 05/2020

Medication Guide

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets s

Read this Medication Guide before you start taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets?

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets can cause serious side effects, including:

**Serious kidney problems.**Rare, but serious kidney problems can happen in people who take medicines made with sodium phosphate, including Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, to clean the colon before colonoscopy. These kidney problems can sometimes lead to kidney failure or the need for dialysis for a long time. These problems often happen within a few days, but sometimes may happen several months after taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets.

Conditions that can make you more at risk for having serious kidney problems with Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets include if you:

• lose too much body fluid (dehydration)
• have slow moving bowels
• have a blockage in your intestine (bowel obstruction)
• have any disease that causes bowel inflammation (colitis)
• have kidney disease or kidney problems
• have heart failure
• take water pills, high blood pressure medicine, or nonsteroidal anti-inflammatory drugs (NSAIDs)

Increased age may increase your risk for having serious kidney problems with Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets.

**Severe fluid loss (dehydration) and severe changes in body salts in the blood (electrolytes).**People who take medicines to clean their colon before a colonoscopy, including Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, can have severe loss of body fluid, with severe changes in body salts in the blood. These changes can be serious and can cause:

• abnormal heart rhythms
• kidney problems
• seizures. This can happen even if you have never had a seizure.

Tell your doctor if you have any of these symptoms of loss of too much body fluid (dehydration) while taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets:

• vomiting
• urinating less often than normal
• dizziness
• headache

See**"What are the possible side effects of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets?"**for more information about side effects.

Important information about taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets:

• Two doses of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are needed to completely prepare for your colonoscopy. Take your first dose of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets on the evening before your colonoscopy. Take your second dose of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets on the morning of your colonoscopy.
• Drink plenty of clear liquids before, during, and after taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. Do not take another laxative or enema that contains sodium phosphate while taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. See*"How should I take Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets?"** for more information about how to take Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets.

What is Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets?

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets is a prescription medicine used in adults to clean your colon before a colonoscopy. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets cleans your colon by causing you to have diarrhea. Cleaning your colon helps your doctor see the inside of your colon more clearly during the colonoscopy.

It is not known if Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are safe and effective in children.

Who should not take Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets?

Do not take Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets if you:

• have had a kidney biopsy that shows you have kidney problems because of too much phosphate.
• have stomach or bowel (intestine) blockage.
• had stomach surgery involving stapling or bypass.
• have an opening in the wall of your intestine (bowel perforation).
• have a severely inflamed colon (toxic colitis).
• have a very dilated intestine (toxic megacolon).
• are allergic to sodium phosphate salts or any of the ingredients in Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. See the end of this Medication Guide for a complete list of ingredients in Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets.

What should I tell my doctor before taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets?

Before you take Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, tell your doctor about all of your medical conditions, including if you:

• have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes).
• have kidney problems.
• have heart problems.
• have a history of seizures.
• have had stomach surgery.
• have stomach or bowel problems.
• have ulcerative colitis.
• have problems with swallowing, gastric reflux, or if you inhale food or fluid into your lungs when eating or drinking (aspirate).
• are withdrawing from alcohol use.
• are withdrawing from the use of a type of medicine called a benzodiazepine.
• are on a low salt diet.
• are pregnant or plan to become pregnant. It is not known if Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets passes into your breast milk. You and your doctor should decide if you will take Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets while breastfeeding.

**Tell your doctor about all the medicines you take,**including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets may affect how other medicines work. Do nottake medicines by mouth within 1 hour of starting each dose of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets or 1 hour after you start taking each dose of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets.

Especially tell your doctor if you take:

• water pills (diuretics).
• medicines for blood pressure or heart problems.
• medicines for kidney problems.
• medicines for pain, such as aspirin or a nonsteroidal anti-inflammatory drug (NSAID).
• medicine for seizures.
• a laxative for constipation.Do not take other laxatives while taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, especially a laxative or enema that contains sodium phosphate.
• medicine for depression or other mental health problem called a benzodiazepine.

Ask your doctor or pharmacist if you are not sure if you take any of the medicines listed above.

Know the medicines you take. Keep a list of your medicines to show your doctor or pharmacist when you get a new prescription.

How should I take Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets?

• Take Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets exactly as prescribed by your doctor. *On the day before your colonoscopy , you can eat a light breakfast before 12:00 PM (noon). Examples of foods that you can eat include: clear liquids and plain yogurt.Do not eat any solid foods on the day before your colonoscopy. After your light breakfast, eat or drink only clear liquids until after your colonoscopy. *It is important for you to drink plenty of clear liquids before, during, and after taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. This may help prevent kidney damage. Examples ofclear liquids are:
• water
• clear soda
• clear broth soups
• gelatin (without added fruit or topping)
• herbal tea, black tea or coffee
• popsicles (without pieces of fruit or fruit pulp)
• watered down (diluted) (from concentrate) clear white grape juice
• strained limeade or lemonade fruit juices (without pulp) including apple juice or *Eat or drink only clear liquids after 12:00 PM (noon) on the day before your colonoscopy until after your colonoscopy. *Do not eat solid food starting on the day before your colonoscopy until after your colonoscopy. *Do not eat or drink alcohol, milk, anything colored red or purple or any foods that have pulp.

You must read, understand, and follow these instructions to take Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets the right way:

On the evening before your colonoscopy,take a total of 20 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, as follows: Step 1. Take 4 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets with 8 ounces ofclear liquids.

Step 2.Wait 15 minutes.

Step 3. Take 4 more Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets with 8 ounces ofclear liquids.

Step 4. Repeat Steps 2 and 3 above, three more times. Make sure you wait 15 minutes after each time.

**On the day of your colonoscopy,**take a total of 12 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets starting about 3 to 5 hours before your colonoscopy, as follows:

Step 1. Take 4 Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets with 8 ounces ofclear liquids.

Step 2.Wait 15 minutes

Step 3. Take 4 more Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets with 8 ounces ofclear liquids.

Step 4. Repeat Steps 2 and 3 one more time.

If you take too much Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, call your doctor or get medical help right away.

What should I avoid while taking****Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets?

• Do not take other laxatives or enemas made with sodium phosphate while taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets.
• Do not use Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets if you have already used it in the last 7 days.

What are the possible side effects of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets?

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets can cause serious side effects, including:

• See**"What is the most important information I should know about Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets?"** *Changes in certain blood tests. Your doctor may do blood tests before and after you take Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets to check your levels of calcium, phosphate, potassium, and sodium in your blood. Tell your doctor if you have any symptoms of too much fluid loss, including:
• vomiting o urinating less often than normal
• dizziness o headache *Abnormal heartbeat (arrhythmias). Tell your doctor if you have an abnormal or irregular heartbeat while taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. *Seizures or fainting (loss of consciousness). People who take a medicine that contains sodium phosphate, such as Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, can have seizures or faint even if they have not had seizures before. Tell your doctor right away if you have a seizure or faint while taking Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. *Sores (ulcers) in the lining of the colon. Tell your doctor right away if you have severe stomach-area (abdomen) pain or rectal bleeding. *Serious allergic reaction. Get emergency medical care right away if you have symptoms of a serious allergic reaction, including:
• swelling of the face, lips, tongue or throat o dizziness or lightheadedness
• problems breathing or wheezing o skin rash
• throat tightness o raised red patches on your skin (hives)
• fainting *The most common side effects of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are:
• bloating stomach (abdominal) pain
• nausea vomiting

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets?

• Store Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets at room temperature, between 68° F to 77° F (20° C to 25° C).
• Throw away any Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets that is not needed.

Keep Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets and all medicines out of the reach of children.

General information about the safe and effective use of Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets for a condition for which it was not prescribed. Do not give Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets to other people, even if they are going to have the same procedure that you are. It may harm them. You can ask your doctor or pharmacist for information that is written for health professionals.

What are the ingredients in Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets?

Active ingredients: monobasic sodium phosphate and dibasic sodium phosphate

Inactive ingredients: polyethylene glycol 8000 and magnesium stearate.

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets is gluten- free.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

Manufactured for:

Lupin Pharmaceuticals Inc.

Baltimore, MD 21202

SAP Code: 265501

Iss. 05/2020

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