Acetaminophen by CVS PHARMACY, INC / GRANULES USA, INC. ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC, GRANULES USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Acetaminophen USP, 500 mg

Purpose

Pain reliever/fever reducer

Uses

 temporarily relieves minor aches and pains due to:
 the common cold

 headache

 backache

 minor pain of arthritis
 toothache

 muscular aches

 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

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 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 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 between 20-25°C (68-77°F). See USP Controlled Room Temperature.
 see bottom of the label for lot number and expiration date

Inactive ingredients

hydroxypropyl methyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Principal display Panel

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-177
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (White to Off-white)	Score	no score
Shape	CAPSULE (Caplet Shape)	Size	17mm
Flavor		Imprint Code	G551
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-177-15	150 in 1 BOTTLE; Type 0: Not a Combination Product	11/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	11/26/2024

Labeler - CVS PHARMACY, INC (062312574)

Registrant - GRANULES USA, INC. (137098864)