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← See all Ibuprofen Pain reliever/ Fever Reducer brands

Ibuprofen Pain reliever/ Fever Reducer

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Chain Drug Consortium
NDC Code: 68016-030

Drug Facts

Active ingredient

Ibuprofen USP, 200mg (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 you ■ you 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 a doctor or pharmacist before use if you are

■ taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin 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 occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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 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

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
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

Other information

store between 20-25 °C (68-77° F). ■ Read all warnings and directions before use Do not use if
seal under bottle cap is broken or missing.

Inactive Ingredients

Colloidal silicon dioxide, corn starch, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin

Questions or Comments?

Call 1-888-952-0050
Monday through Friday 9AM – 5PM EST

Package/Label Principal Display Panel
IBUPROFEN  PAIN RELIEVER/ FEVER REDUCER
ibuprofen 200 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-030
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STARCH, CORN 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize17mm
FlavorImprint CodeIBU200
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-030-1450 TABLET in 1 CARTON
2NDC:68016-030-16100 TABLET in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA01935512/30/2014
Labeler - Chain Drug Consortium (101668460)
Registrant - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIOperations
Allegiant Health079501930LABEL(68016-030), MANUFACTURE(68016-030), PACK(68016-030), RELABEL(68016-030), REPACK(68016-030)

Revised: 12/2014
 
Chain Drug Consortium

← See all Ibuprofen Pain reliever/ Fever Reducer brands

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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