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IBUPROFEN by ADVANCED FIRST AID, INC.

Medically reviewed on April 9, 2018

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 2001
Labeler: ADVANCED FIRST AID, INC.
NDC Code: 67060-750

ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)

pain reliever/fever reducer

Uses:

temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • toothache • menstrual cramps • common cold • 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 • 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 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 an NSAID [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 use if you have: • problems or serious side effects from taking pain relievers or fever reducers • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain •

ulcers • bleeding problems • high blood pressure • heart disease, liver cirrhosis, or kidney disease • taken a diuretic • reached age 60 or older

Ask a 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 feel faint, vomit blood, or 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 specifically 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.

Directions:

Adults and children 12 years of age and older:

• do not take more than directed • the smallest effective dose should be used • 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 of age: do not use for children under 12 years of age unless directed by a doctor.

Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelantinized starch, talc, titanium dioxide.

IBUPROFEN 
ibuprofen 200mg tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-750
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POLYVINYL ALCOHOL 
STARCH, PREGELATINIZED CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeIBU;200
Contains    
Packaging
#Item CodePackage Description
1NDC:67060-750-68100 PACKET in 1 CARTON
12 TABLET, FILM COATED in 1 PACKET
2NDC:67060-750-67250 PACKET in 1 CARTON
22 TABLET, FILM COATED in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912904/09/2015
Labeler - ADVANCED FIRST AID, INC. (114477180)
Registrant - ADVANCED FIRST AID, INC. (114477180)
Establishment
NameAddressID/FEIOperations
ULTRA SEAL CORPORATION085752004pack(67060-750)
Establishment
NameAddressID/FEIOperations
SHAUN PHARMACEUTICALS LIMITED915786829manufacture(67060-750)

 
ADVANCED FIRST AID, INC.

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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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