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Ibuprofen by Bryant Ranch Prepack

Medically reviewed on Jan 1, 2018

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Bryant Ranch Prepack
NDC Code: 71335-0223

Drug Facts

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti- inflammatory drug 

Purpose

Pain Reliever/ Fever Reducer

Uses

temporarily relieves minor aches and pain due to:

  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis
  • 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 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 non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks everyday 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
  • 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 or asthma
  • you are taking a diuretic

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

when using this product
  • take with food or milk if stomach upset occurs
  • the 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 last for more than 10 days
  • fever gets worse or last 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). This Package for Households Without Young Children.

Directions
  • do not take more than directed
  • the smallest effective dose should be used

adults and children
12 years and older
  • take 1 tablet every4 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
  • consult a doctor

Other information
  • Tamper Evident: do not use if safety seal under cap is broken or missing
  • store at room temperature (20o- 25oC) 
  • avoid excessive heat above 40oC (104oF)

Inactive Ingredients:

colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, red iron oxide, talc & titanium dioxide  

Questions? Adverse drug event call: (800)687-0176 Mon-Fri: 8 AM to 4 PM

*This product is not manufactured or distributed by Pfizer Consumer Products, owner of the registered trademark ADVIL®.

HOW SUPPLIED

Product: 71335-0223

NDC: 71335-0223-5 60 TABLET in a BOTTLE

NDC: 71335-0223-8 10 TABLET in a BOTTLE

NDC: 71335-0223-2 15 TABLET in a BOTTLE

NDC: 71335-0223-3 30 TABLET in a BOTTLE

NDC: 71335-0223-0 90 TABLET in a BOTTLE

NDC: 71335-0223-9 56 TABLET in a BOTTLE

NDC: 71335-0223-6 50 TABLET in a BOTTLE

NDC: 71335-0223-7 40 TABLET in a BOTTLE

NDC: 71335-0223-1 20 TABLET in a BOTTLE

NDC: 71335-0223-4 100 TABLET in a BOTTLE

Ibuprofen 200mg Tablet
IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0223(NDC:66424-396)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL 3350 
POLYVINYL ALCOHOL, UNSPECIFIED 
STARCH, CORN 
FERRIC OXIDE RED 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code114
Contains    
Packaging
#Item CodePackage Description
1NDC:71335-0223-560 TABLET in 1 BOTTLE
2NDC:71335-0223-810 TABLET in 1 BOTTLE
3NDC:71335-0223-215 TABLET in 1 BOTTLE
4NDC:71335-0223-330 TABLET in 1 BOTTLE
5NDC:71335-0223-090 TABLET in 1 BOTTLE
6NDC:71335-0223-956 TABLET in 1 BOTTLE
7NDC:71335-0223-650 TABLET in 1 BOTTLE
8NDC:71335-0223-740 TABLET in 1 BOTTLE
9NDC:71335-0223-120 TABLET in 1 BOTTLE
10NDC:71335-0223-4100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123903/01/2016
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIOperations
Bryant Ranch Prepack171714327REPACK(71335-0223), RELABEL(71335-0223)

 
Bryant Ranch Prepack

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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