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Regular Strength Aspirin by WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

Dosage form: tablet, film coated
Ingredients: ASPIRIN 400mg, CAFFEINE 32mg
Labeler: WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
NDC Code: 59779-164

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.

CVS 44-164

Active ingredient(s)

Aspirin (NSAID)*400 mg

Caffeine 32 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever aid

Use(s)
  • temporarily relieves minor aches and pains due to:

  • headache

  • a cold

  • muscular aches

  • toothache

  • arthritis

  • menstrual cramps

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:

  • hives

  • facial swelling

  • shock

  • asthma (wheezing)

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 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

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Do not use
  • if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if
  • stomach bleeding warning applies to you

  • you have a history of stomach problems, such as heartburn

  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

  • you have asthma

  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

  • gout

  • diabetes

  • arthritis

Stop use and ask a doctor if
  • you experience any of the following signs of stomach bleeding:

  • feel faint

  • have bloody or black stools

  • vomit blood

  • have stomach pain that does not get better

  • an allergic reaction occurs. Seek medical help right away.

  • new symptoms occur

  • redness or swelling is present

  • ringing in the ears or loss of hearing occurs

  • pain gets worse or lasts more than 10 days

  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

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 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.

Directions
  • do not use more than directed

  • drink a full glass of water with each dose

  • adults and children 12 years of age and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor

  • children under 12 years: do not use unless directed by a doctor

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

  • see end flap for expiration date and lot number

Inactive ingredients

hypromellose, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate

Questions or comments?

1-800-426-9391

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

CVS®

pharmacy

NDC 59779-164-17

Compare to the active ingredients in Anacin®†

See New Warnings Information

NEW!

Regular Strength

ASPIRIN

FAST ACTING WITH CAFFEINE

ASPIRIN 400 MG (NSAID), CAFFEINE 32 MG

PAIN RELIEVER/PAIN RELIEVER AID

300 COATED TABLETS

Easy to swallow

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844        ORG031016417

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2010 CVS/pharmacy

www.cvs.com     1-800-shop-CVS

Product Packaging

REGULAR STRENGTH ASPIRIN 
aspirin and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-164
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN400 mg
CAFFEINE (CAFFEINE) CAFFEINE32 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code44;164
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-164-171 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
1300 TABLET, FILM COATED (300 TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/01/2011
Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)

Revised: 05/2011
 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

← See all Regular Strength Aspirin brands

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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