EXTRA STRENGTH PAIN RELIEF- acetaminophen tablet, coated

Drug Details [pdf]

Active Ingredient (in each tablet)

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

Do not use with any other drug containing acetaminophen (prescription or non prescription). 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 DOCTOR

Ask a doctor before use if you have liver disease
ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are if you are taking the blood thinning drug warfarin
STOP USE

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.
PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
OVERDOSAGE

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 & children 12 years & 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 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)
Inactive ingredients

Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Questions or comments?

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Label

NDC: 82501-1575-1

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Compare to active ingredient in Extra Strength Tylenol®†

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EXTRA STRENGTH
Pain Relief
Acetaminophen

500 mg

100 CAPLETS

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEF
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82501-1575
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, POTATO (UNII: 8I089SAH3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	S500
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 82501-1575-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	05/11/2022

Labeler - Gobrands, Inc (057499049)

Registrant - Prodose, Inc. (119371190)

EXTRA STRENGTH PAIN RELIEF- acetaminophen tablet, coated

Extra Strength Pain Relief by

Drug Labeling and Warnings

Drug Details [pdf]