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Ibuprofen by Chain Drug Consortium

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Chain Drug Consortium
NDC Code: 68016-059

Drug Facts

Active ingredient

Ibuprofen UDP, 200 mg (NSAID) **
**nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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

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 a nonsteroidal anti-inflammatory drug (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.

Do Not Use

if you have ever had an allergic reaction to 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 youyou have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you have asthma you are taking a diuretic

Ask doctor or pharmacist before use if

you are taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) or steroid drug 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
long term continuous use may increase the risk of heart attack or stroke

Stop use and ask a doctor if

you faint, vomit blood, have bloody or black stools. These are signs of stomach bleeding. pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days stomach pain or upset gets worse or lasts 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 during the last 3 months of 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).

Directions

do not take more than directed
■ the smallest effective dose should be used
do not take longer than 10 days, unless directed by a doctor (see Warnings)
Adults and children 12 years and older:take 1 tablet every 4 to 6 hours while symptoms persist
■ if pain or fever does not respond to 1 tablet, 2 tablets may be used ■ do not exceed 6 tablets in 24 hours unless directed by a doctor
Children under 12 years: ask a doctor

Inactive Ingredients

Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch (Corn), Titanium Dioxide

Package/Label Principal Display Panel
IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-059
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
HYPROMELLOSES 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
POVIDONES 
SODIUM LAURYL SULFATE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-059-1324 TABLET in 1 BOX
2NDC:68016-059-1450 TABLET in 1 BOX
3NDC:68016-059-16100 TABLET in 1 BOX
4NDC:68016-059-28250 TABLET in 1 BOX
5NDC:68016-059-17500 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912911/04/2014
Labeler - Chain Drug Consortium (101668460)
Registrant - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIOperations
A&Z Pharmaceutical, Inc.926820705LABEL(68016-059), MANUFACTURE(68016-059), PACK(68016-059), RELABEL(68016-059), REPACK(68016-059)

Revised: 11/2014
 
Chain Drug Consortium

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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