MedPath

Ibuprofen

1112C-HTE-2025-0520

Approved
Approval ID

637210f0-6494-4656-8b2b-14d7476cb127

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

Teeter

DUNS: 047279351

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ibuprofen

PRODUCT DETAILS

NDC Product Code72036-212
Application NumberANDA202312
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 20, 2025
Generic NameIbuprofen

INGREDIENTS (11)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
IBUPROFENActive
Quantity: 200 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/20/2025

PRINCIPAL DISPLAY PANEL

Harris Teeter™

NDC 72036-212-02

Ibuprofen

†Compare to the Active Ingredient in Motrin® IB

Tablets, 200 mg

PAIN RELIEVER / FEVER REDUCER (NSAID)

50 COATED CAPLETS**

**Capsule-Shaped Tablets

Actual Size

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/24/2019

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
  • temporarily reduces fever

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/24/2019

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/14/2025

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/24/2019

Purposes

Pain reliever/fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 5/14/2025

Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chances are higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Heart attack and stroke warning

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

  • if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

■ you experience any of the following signs of stomach bleeding:

■ feel faint

■ vomit blood

■ have bloody or black stools

■ have stomach pain that does not get better

■ you have symptoms of heart problems or stroke:

■ chest pain

■ trouble breathing

■ weakness in one part or side of body

■ slurred speech

■ leg swelling

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ redness or swelling is present in the painful area

■ any new symptoms appear

**If pregnant or breast-feeding,**ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

**Keep out of reach of children.**In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/14/2025

Directions

■** do not take more than directed**

the smallest effective dose should be used

■ adults and children 12 years and older:

■ take 1 caplet every 4 to 6 hours while symptoms persist

■ if pain or fever does not respond to 1 caplet, 2 caplets may be used

■ do not exceed 6 caplets in 24 hours, unless directed by a doctor

■ children under 12 years: ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/14/2025

Other information

  • read all warnings and directions before use
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/14/2025

Inactive ingredients

colloidal silicon dioxide, corn starch, FD&C yellow #6, polyethylene glycol, polyvinyl alcohol, povidone K30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/20/2025

Questions or comments?

1-844-705-4384

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