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Aspirin by Bryant Ranch Prepack

Medically reviewed on Jul 30, 2018

Dosage form: tablet
Ingredients: ASPIRIN 81mg
Labeler: Bryant Ranch Prepack
NDC Code: 63629-2825

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Aspirin Tablets (NSAID)
* nonsteroidal anti-inflammatory drug

Active Ingredient

(in each tablet)

Aspirin 81 mg

Purpose

Pain Reliever

Uses
  • Temporarily relieves minor aches and pains
  • For other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

Warnings

Reye’s Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early signs of  Reye’s syndrome, a rare but serious illness.

Allergy Alert: Aspirin may cause a severe allergic reaction which may include

  • Hives
  • facial swelling
  • asthma (wheezing)
  • shock

    Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding.

    The chances 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 (ibuprofen, naproxen, or others)
  • take more or for longer time than directed
  • have 3 or more alcoholic drinks every day while using this product

    Do not use if you have ever had an allergic reaction to any other pain reliever / fever reducer

    Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

    Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout or arthritis
  • under a doctor’s care for any serious condition
  • taking any other drug

    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 symptoms appear
  • ringing in the ears or loss of hearing occurs

    If pregnant or breast feeding,  ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complication during delivery.

    Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

  • adults and children 12 years & older: take 4 or 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours
  • children under 12 years: ask a doctor

Other Information
  • store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

croscarmellose sodium, D&C Yellow # 10 (AL-lake), HPMC, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol/propylene glycol, PVP, silicon dioxide, sodium lauryl sulfate, corn starch, stearic acid, talc, titanium dioxide

Questions or Comments

Call 1-800-645-2158, 9am–5pm ET, Monday - Friday

Aspirin 81 mg EC Tablet

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-2825(NDC:0536-3086)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
HYPROMELLOSES 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
POVIDONE K30 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
STARCH, CORN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeAP;121
Contains    
Packaging
#Item CodePackage Description
1NDC:63629-2825-1120 TABLET in 1 BOTTLE
2NDC:63629-2825-230 TABLET in 1 BOTTLE
3NDC:63629-2825-3100 TABLET in 1 BOTTLE
4NDC:63629-2825-420 TABLET in 1 BOTTLE
5NDC:63629-2825-590 TABLET in 1 BOTTLE
6NDC:63629-2825-660 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34304/28/2008
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIOperations
Bryant Ranch Prepack171714327REPACK(63629-2825), RELABEL(63629-2825)

 
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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