DrugCite

REGULAR STRENGTH ASPIRIN - aspirin and caffeine tablet, film coated 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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

Product Packaging


REGULAR STRENGTH ASPIRIN 
aspirin and caffeine  tablet, film coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 59779-164
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 400 mg
CAFFEINE (CAFFEINE) CAFFEINE 32 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL  
SODIUM LAURYL SULFATE  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 44;164
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 59779-164-17 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
1 300 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (59779-164-17)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 01/01/2011

Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)
Revised: 05/2011WOONSOCKET PRESCRIPTION CENTER,INCORPORATED