Ibuprofen
Drug Facts
3ed7faff-fd48-0a83-e063-6394a90aab14
HUMAN OTC DRUG LABEL
Sep 15, 2025
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
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
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
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
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.
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 - 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 - WHEN USING SECTION
When using this product
- take with food or milk if stomach upset occurs
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 - 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.
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.
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
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.
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
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 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