ACETAMINOPHEN- acetaminophen tablet, film coated 
CVS Pharmacy

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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CVS Pharmacy, Inc. Acetaminophen Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 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 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.

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 you have ever had an allergic reaction to this product or any of its ingredients

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 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 use for more than 10 days unless directed by a doctor

children under

12 years

ask a doctor

Other information

•
store at 20-25°C (68-77°F)

Inactive ingredients

carnauba wax, croscarmellose sodium, crospovidone, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredient in Tylenol® Rapid Release Gels

Rapid Release Caplets

EXTRA STRENGTH

Acetaminophen Caplets, 500 mg

Pain reliever;

Fever reducer

Aspirin free

For Adults

RAPID RELEASE

DYE FREE

100 CAPLETS

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8g1-17-acetaminophen-2.jpg
ACETAMINOPHEN 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-707
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint Code 8G1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-707-78100 in 1 BOTTLE; Type 0: Not a Combination Product01/12/201812/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/12/201812/31/2021
Labeler - CVS Pharmacy (062312574)

Revised: 12/2022
Document Id: af24edb2-ef7e-47c6-9d3e-f3cd3a99a04c
Set id: 5d903ad2-d20b-4938-84f2-9cfa9b09d95d
Version: 3
Effective Time: 20221220
 
CVS Pharmacy