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Name:Aspirin
Manufacturer:Cispharma, Inc
Category:Over-the-counter (OTC) Marketed Drugs


ASPIRIN ENTERIC COATED YELLOW TABLETS, 81 mg

ASPIRIN - aspirin tablet, coated 
Cispharma, Inc

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.

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ASPIRIN ENTERIC COATED YELLOW TABLETS, 81 mg

Drug Facts

Active ingredient (in each tablet)

Aspirin (NSAID*) .............................. 81 mg

*Nonsteroidal anti-inflammatory drug

Pain Reliever

Uses

For the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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 sign of Reye's syndrome, a rare but serious illness.

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

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

Alcohol Warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

Do not use if you have ever had an allergic reaction to any other pain relievers/fever reducers.

Ask a doctor before use if you have

  • stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
  • bleeding problems
  • ulcers
  • asthma

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • diabetes
  • gout
  • arthritis
  • anticoagulation ( thinning of blood)

Indicated for pain relief.

Stop use and ask a doctor if

  • An allergic reaction occurs. Seek medical help right away
  • Pain gets worse or lasts more than 10 days
  • Redness or swelling is present
  • New symptoms occur
  • 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 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 immediately.

Directions:

  • drink a full glass of water with each dose.
  • adults and children 12 years of age and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by doctor.
  • Children under 12 years: consult a doctor

Other Information

  • Store at room temperature

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C Yellow # 10 al lake, FD&C Yellow # 6 al lake, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl citrate

Questions or Comments?
Call 1-866-383-9908

Manufactured by:

Cispharma Inc
1212 Cranbury S River Road
Cranbury, NJ 08512

ASPIRIN ENTERIC COATED YELLOW TABLETS, 81 mg, Bulk

ASPIRIN 
aspirin tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52204-103
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
D&C YELLOW NO. 10  
FD&C YELLOW NO. 6  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
MICROCRYSTALLINE WAX  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
TRIETHYL CITRATE  
Product Characteristics
Color YELLOW (YELLOW) Score no score
Shape ROUND (Round) Size 6mm
Flavor Imprint Code C;3
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52204-103-99 166667 TABLET, COATED ( TABLET) in 1 DRUM None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 02/14/2011

Labeler - Cispharma, Inc (833171445)
Registrant - Cispharma, Inc (833171445)
Establishment
Name Address ID/FEI Operations
Cispharma, Inc 833171445 manufacture

Revised: 04/2011 Cispharma, Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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