MedPath

Ibuprofen

Ibuprofen Caplets, 200 mg

Approved
Approval ID

34440532-03e1-4feb-b3e2-dab869edeb15

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Feb 1, 2025

Manufacturers
FDA

BI-MART

DUNS: 027630078

Products 1

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

Ibuprofen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code37835-585
Application NumberANDA079174
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2025
FDA Product Classification

INGREDIENTS (10)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC37835-585-25

Compare to the active ingredient in Advil ®Caplets*

IBUPROFEN CAPLETS, 200 mg

  • Pain Reliever
  • Fever Reducer (NSAID)

250 Caplets

*This product is not manufactured or distributed by owner of the registered trademark Advil ®Caplets.

Distributed by

**BI-MART,**Eugene, OR 97402

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/20/2025

Uses

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/20/2025

Other Information

  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/20/2025

Active Ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)******

**nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/20/2025

PURPOSE

Pain reliever/ Fever reducer

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 5/20/2025

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/20/2025

When using this product

  • take with food or milk if stomach upset occurs

WARNINGS SECTION

LOINC: 34071-1Updated: 5/20/2025

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 chance is 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.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/20/2025

Do not use

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

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/20/2025

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/20/2025

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 5/20/2025

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/20/2025

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/20/2025

Directions

*do not take more than directed *the smallest effective dose should be used

adults and children 12 years and over

* 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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/20/2025

Inactive ingredients

colloidal silicon dioxide, iron oxide red, maize starch, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

OTC - QUESTIONS SECTION

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

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Ibuprofen - FDA Drug Approval Details