ACETAMINOPHEN- acetaminophen tablet, film coated 
CVS Pharmacy, Inc

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.

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1190-CVS

Drug Facts

Active ingredient (in each caplet)
Acetaminophen 500 mg

Purpose
Pain reliever/fever reducer

Uses

 temporarily relieves minor aches and pains due to  the common cold  headache  toothache
 muscular aches

 backache

 minor pain of arthritis

 premenstrual and menstrual cramps
 temporarily reduces fever

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

 more than 4,000 mg of acetaminophen in 24 hours

 with other drugs containing acetaminophen

 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.

 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 you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

 pain gets worse or lasts more than 10 days

 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 of age
and over
 take 2 caplets every 6 hours while symptoms last
 do not take more than 6 caplets in 24 hours, unless directed by a doctor
 do not take for more than 10 days unless directed by a doctor
children under 12
years of age
 ask a doctor

Other information

 Store in a dry place at 15° – 30°C (59° – 86°F)

corn starch, hypromellose, mineral oil, polyethylene glycol, povidone, sodium lauryl sulfate, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

Call 1-800-231-4670

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2021 CVS/pharmacy

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®.

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

CVS Health

Compare to the active ingredient in Extra Strength Tylenol®*

Extra Strength

Acetaminophen

Caplets 500 mg

Pain reliever; Fever reducer

1000 Caplets

CVS Label

ACETAMINOPHEN 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-864
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code CPC1190
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-864-041000 in 1 BOTTLE; Type 0: Not a Combination Product03/17/2021
2NDC:69842-864-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/06/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/17/2021
Labeler - CVS Pharmacy, Inc (062312574)

Revised: 10/2021
Document Id: c4473ee6-4e02-1ec2-e053-2995a90ac513
Set id: c4473ee6-4e01-1ec2-e053-2995a90ac513
Version: 1
Effective Time: 20211027
 
CVS Pharmacy, Inc