Acetaminophen by CVS Pharmacy, Inc. ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
• headache
• the common cold
• backache
• minor pain of arthritis
• toothache
• muscular aches
• 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 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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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

■ adults and children 12 years and over:

■ take 2 tablets every 6 hours while symptoms last

■ do not take more than 6 tablets 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: ask a doctor

Other information

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ see end flap for expiration date and lot number

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate and stearic acid

Questions or comments?

1-800-231-4670

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by McNeil

Consumer Healthcare, owner of the registered trademark

Extra Strength Tylenol®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2018 CVS/pharmacy CVS.com®

1-800-SHOP CVS V-34571

PRINCIPAL DISPLAY PANEL

CVSHealth

Compare to the active ingredient in Extra Strength Tylenol®*

EXTRA STRENGTH

Acetaminophen

Tablets 500 mg

Pain reliever; Fever reducer

Aspirin free

100 TABLETS

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-465
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
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	CPC;546
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-465-12	1 in 1 CARTON	08/06/2018
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	08/06/2018

Labeler - CVS Pharmacy, Inc. (062312574)