Asprin

Dosage form: tablet, delayed release
Ingredients: ASPIRIN 81mg
Labeler: Avema Pharma Solutions
NDC Code: 63548-3602

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.

Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses
  • temporarily relieves minor aches and pains
  • other therapy as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief.

Warnings

Reye’s syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s syndrome, a rare but serious illness reported to be associated with aspirin.

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

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

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 prescription or nonprescription NSAIDs (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 before use if you have:
  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
  • bleeding problems
  • ulcers
  • asthma
  • high blood pressure
  • heart or kidney disease
  • liver cirrhosis
  • taken a diuretic
  • reached the age of 60 or older

Ask a doctor or pharmacist before use if you are taking a prescription drug for:
  • anticoagulation (thinning of the blood)
  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if
  • an allergic reaction occurs. Seek medical help right away.
  • pain gets worse or lasts for more than 10 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs
  • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.

If pregnant or breast-feeding, ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN 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 THE DELIVERY. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • do not exceed recommended dosage
  • 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 a doctor
  • children under 12 years of age: consult a doctor
  • do not use in children under 4 years of age

Other information

store at controlled room temperature 15°-30°C (59°-86°F)

do not use if imprinted safety seal under cap is broken or missing

**This product is not manufactured or distributed by Bayer Corporation Consumer Care Division, owner of the registered trademark Aspirin Regimen Bayer® 81 mg

Inactive ingredients

*acetylated monoglycerides, *anhydrous lactose, colloidal silicon dioxide, *corn starch, *croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, *hypromellose phthalate, *iron oxide Yellow (iron oxide ochre), methacrylic acid copolymer, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG)-400, *polysorbate 80, pregelatinized starch, *propylene glycol, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacitin, and triethyl citrate. *May also contain.

Package/Label Principal Display Panel

NDC 63548-3602-*1

**Compare to the active ingredient in Aspirin Regimen Bayer® 81mg

SEE NEW WARNINGS INFORMATION

ENTERIC SAFETY COATED

ASPIRIN 81 mg

Pain Reliever (NSAID)*

Low Dose · Asprin Regimen**

300 ENTERIC COATED TABLETS

ASPRIN 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-3602
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSE 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
SODIUM BICARBONATE 
SODIUM LAURYL SULFATE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize3mm
FlavorImprint CodeE
Contains    
Packaging
#Item CodePackage Description
1NDC:63548-3602-1300 TABLET, DELAYED RELEASE (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34301/02/2010
Labeler - Avema Pharma Solutions (804087749)

Revised: 02/2010
 
Avema Pharma Solutions

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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