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ASPIRIN by Cispharma, Inc

Medically reviewed on April 17, 2018

Dosage form: tablet, coated
Ingredients: ASPIRIN 325mg
Labeler: Cispharma, Inc
NDC Code: 52204-111

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 ENTERIC COATED ORANGE TABLETS, 325 mg

Drug Facts

Active ingredient (in each tablet)

Aspirin (NSAID*) .............................. 325 mg

Pain Reliever

Uses

For the temporary relief of minor aches and pains due to headache, minor arthritis, colds, muscle pain, toothache, menstrual pain, or as recommended by your doctor

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 or allergic reaction to aspirin
  • 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:
  • Do not take more than directed
  • Adults and children 12 years of age and over: take 1 to 2 tablets every 4 while symptoms persist. Drink a full glass of water with each dose. Do not take more than 12 tablets in 24 hours unless directed by a doctor
  • Children under 12 years: consult a doctor

Other Information
  • Store below 25°C

Inactive Ingredients

colloidal silicon dioxide, FD&C Yellow # 6 al lake, hypromellose, methacrylic acid copolymer, starch, talc, titanium dioxide, triacetin, triethyl citrate

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

Manufactured by:

Cispharma Inc
1212 Cranbury S River Road
Cranbury, NJ 08512

ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52204-111
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
HYPROMELLOSE 2910 (5 MPA.S) 
FD&C YELLOW NO. 6 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
Product Characteristics
ColorORANGE (ORANGE) Scoreno score
ShapeROUND (Round) Size11mm
FlavorImprint CodeC;11
Contains    
Packaging
#Item CodePackage Description
1NDC:52204-111-9941026 TABLET, COATED (TABLET) in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34311/15/2010
Labeler - Cispharma, Inc (833171445)
Registrant - Cispharma, Inc (833171445)
Establishment
NameAddressID/FEIOperations
Cispharma, Inc833171445manufacture

 
Cispharma, 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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