ACETAMINOPHEN tablet, film coated

ACETAMINOPHEN by

Drug Labeling and Warnings

ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by Walgreens Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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
  • 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 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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

Do not take more than directed.

SEE OVERDOSE WARNING.

• adults & 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 doctor
  • do not take more than 10 days, unless directed by a doctor
• children under 12 years of age:
  • ask a doctor

Other information

• store at room temperature between 20-25° C (68-77° F)
• avoid excessive heat, cold and humidity
• close cap tightly after use

Inactive ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

call 1 (888) 577-8033

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DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 30 Caplet Bottle Carton

BONUS SIZE | 24 + 6 FREE
NDC: 0363-0143-03

Walgreens

Compare to Tylenol® Extra Strength
Caplets active ingredient††

Pain Reliever
ACETAMINOPHEN 500 mg / PAIN RELIEVER / FEVER REDUCER

EXTRA STRENGTH
CAPLETS

30 CAPLETS

ACTUAL SIZE

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0143
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
hypromellose, unspecified (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
microcrystalline cellulose (UNII: OP1R32D61U)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
povidone, unspecified (UNII: FZ989GH94E)
stearic acid (UNII: 4ELV7Z65AP)
talc (UNII: 7SEV7J4R1U)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	S500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0143-03	1 in 1 CARTON	04/01/2020
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0363-0143-06	1 in 1 CARTON	04/01/2020
2		60 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	04/01/2020

Labeler - Walgreens Co. (008965063)