ACETAMINOPHEN- acetaminophen capsule 
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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Acetaminophen 500mg Gelcaps

Active ingredient

(in each Gelcap)

Acetaminophen, USP 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

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. 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 reaction. 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 the reach of children

Keep out of the reach of children

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 gelcaps every 6 hours while symptoms last

■ do not take more than 6 gelcaps 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 between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.

■ avoid high humidity

■ see end panel for lot number and expiration date

Inactive ingredients

ammonium hydroxide, black iron oxide, black iron oxide irradiated, colloidal silicon dioxide, croscarmellose sodium, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone k-30, pregelatinized starch, propylene glycol, shellac glaze (modified), stearic acid, titanium dioxide, yellow iron oxide.

Questions or comments?

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

225 count

ACETAMINOPHEN 
acetaminophen capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-302
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GELATIN (UNII: 2G86QN327L)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
AMMONIA (UNII: 5138Q19F1X)  
Product Characteristics
Colorred, blue, grayScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code G1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-302-0124 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2015
2NDC:69842-302-0230 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2015
3NDC:69842-302-0350 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2015
4NDC:69842-302-04100 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2015
5NDC:69842-302-05120 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2015
6NDC:69842-302-06225 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2015
7NDC:69842-302-07300 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2015
8NDC:69842-302-08400 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/02/201503/29/2019
Labeler - CVS PHARMACY, INC (062312574)

Revised: 3/2019
 
CVS PHARMACY, INC