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pain relief by CVS Pharmacy

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: CVS Pharmacy
NDC Code: 59779-766

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 Pharmacy, Inc. Pain Relief Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses
temporarily relieves minor aches and pains due to:
headache
muscular aches
backache
minor pain of arthritis
the common cold
toothache
premenstrual and menstrual cramps
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if the user has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if the user
has liver disease
is a child with pain of arthritis

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

Stop use and ask a doctor if
pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
do not take more than directed (see overdose warning)

adults and children 12 years and over

take 2 tablets every 4 to 6 hours while symptoms last
do not take more than 10 tablets in 24 hours
do not use for more than 10 days unless directed by a doctor

children 6-11 years

take 1 tablet every 4 to 6 hours while symptoms last
do not take more than 5 tablets in 24 hours
do not use for more than 5 days unless directed by a doctor

children under 6 years

ask a doctor

Inactive ingredients

croscarmellose sodium*, povidone, pregelatinized starch, stearic acid *may contain this ingredient

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Regular Strength Tylenol®

Tablets

Regular Strength

Pain Relief

ACETAMINOPHEN 325 mg

Pain reliever; Fever reducer

Contains no aspirin

100 TABLETS

Actual Size

PAIN RELIEF 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-766
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
POVIDONES 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (beveled edge) Size10mm
FlavorImprint Code325MG;L403
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-766-781 BOTTLE in 1 CARTON
1100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/15/1991
Labeler - CVS Pharmacy (062312574)

Revised: 12/2017
 
CVS Pharmacy

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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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