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FDA Approval

IBUPROFEN

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 27, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Ibuprofen(200 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Bionpharma Inc.

079637826

Manufacturing Establishments2

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

ESJAY PHARMA PRIVATE LIMITED

DISCOUNT DRUG MART, INC.

Bionpharma Inc.

957309497

Patheon Softgels Inc.

DISCOUNT DRUG MART, INC.

Bionpharma Inc.

002193829

Products1

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

IBUPROFEN

Product Details

NDC Product Code
53943-212
Application Number
ANDA078682
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 27, 2025
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SORBITANInactive
Code: 6O92ICV9RUClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 200 mg in 1 1

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

160's label-MADE IN INDIA

DISCOUNT

drug

mart

FOOD FAIR

IBUPROFEN

CAPSULES, 200 mg

Pain Reliever/Fever Reducer (NSAID)

†Compare to the active ingredient in Advil ®LIQUI-GELS ®

160 SOFTGELS**

**(Liquid filled capsules)

front

back


INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

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

  • adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 capsule, 2 capsules may be used
  • do not exceed 6 capsules in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

WARNINGS SECTION

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 be fatal. The risk is higher if you use more than directed or for longer than directed.


STORAGE AND HANDLING SECTION

Other information

  • each capsule contains:potassium 20 mg
  • read all warnings and directions before use. keep carton.
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat above 40°C (104°F). Protect from light.

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose

Pain reliever/Fever reducer

OTC - ASK DOCTOR SECTION

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 - ASK DOCTOR/PHARMACIST SECTION

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 - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - DO NOT USE SECTION

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 - STOP USE SECTION

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 - WHEN USING SECTION

When using this product

  • take with food or milk if stomach upset occurs

OTC - QUESTIONS SECTION

Questions or comments?

call toll free1-888-235-2466

**DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH ****“SEALED for YOUR PROTECTION”**IS BROKEN OR MISSING.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

†All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Advil ®LIQUI-GELS ®.

Distributed by: Discount Drug Mart

211 Commerce Drive, Medina, Ohio 44256

www.discount-drugmart.com

R0422

L0000607

For India Manufacturing Site:

MADE IN INDIA

Code: TN/DRUGS/TN/25/00074

L0000977

R0125

P3282/00/25

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 delivery problems in the unborn child or complications during delivery.


INACTIVE INGREDIENT SECTION

Inactive ingredients

FD&C Blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol

For India Manufacturing Site:

FD&C Blue #1, gelatin, polyethylene glycol,potassium hydroxide, purified water, sorbitan and sorbitol


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