MedPath

Ibuprofen

Drug Facts

Approved
Approval ID

3ed7faff-fd48-0a83-e063-6394a90aab14

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

Chain Drug Marketing Association, Inc.

DUNS: 011920774

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 Code83324-207
Application NumberANDA078682
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (8)

FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
IBUPROFENActive
Quantity: 200 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/15/2025

80's carton-Made In India label

NDC 83324-207-80

QC ®

QUALITY CHOICE

† Compare to the

Active Ingredient in

Advil ® LIQUI-GELS ®

Ibuprofen

Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)

actual size

80Softgels**

**Liquid Filled Capsules

carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/15/2019

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/15/2019

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

LOINC: 55105-1Updated: 10/15/2019

Purpose

Pain reliever/Fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 10/15/2019

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.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 10/15/2019

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: 10/15/2019

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

LOINC: 50568-5Updated: 10/15/2019

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: 10/15/2019

When using this product

  • take with food or milk if stomach upset occurs

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 10/15/2019

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: 12/27/2022

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 10/15/2019

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/15/2019

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 10/15/2019

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.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/9/2025

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/15/2025

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 C.D.M.A., Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

MADE IN INDIA
Code: TN/DRUGS/TN/25/00074

P3459/00/25

R0325 L0001021

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Ibuprofen - FDA Drug Approval Details