Acetaminophen 500 mgExtra Strength

ACETAMINOPHEN by

Drug Labeling and Warnings

ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by Akron Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACETAMINOPHEN- acetaminophen tablet 
Akron Pharma Inc.

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Acetaminophen 500 mg
Extra Strength

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

To reduce fever and for the temporary relief of 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.

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if 

• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours 
• taken with other drugs containing acetaminophen 
• adult has 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if the user has ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if the user has

• has liver disease

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Stop use and ask a doctor if:

• pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
• 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:

Taking more than the recommended dose (overdose) may cause liver damage. 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 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 use for more than 10 days unless directed by a doctor
• child under 12 years: ask a doctor

Other information

• store at temperature 15° to 30°C (59° to 86°F)

Inactive Ingredients:

croscannellose sodium, hydroxypropyl cellulose, colloidal silicon dioxide, microcrystalline cellulose, propyl paraben, povidone, stearic acid.

Questions or Comments?

Call toll-free 1-877-225-6999

Manufactured for
Akron Pharma, Inc.,

373 RT US46 W Building E,

Suite 117, Fairfeld, NJ - 07004

Mfg. Lic. No: TN/DRUGS/558/1997

* This product is not manufactured or distributed by Johnson and Johnson, consumer inc., distributor of regular Tylenol Tablets.

500mg-100 Tablets

500mg-1000 Tablets

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-8022
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor		Imprint Code	AP500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-8022-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2021	11/03/2024
2	NDC: 71399-8022-2	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2021	11/03/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/15/2021	11/03/2024

Labeler - Akron Pharma Inc. (067878881)

Registrant - Akron Pharma Inc. (067878881)

Revised: 11/2024

Document Id: e8875c52-0892-460b-8419-31f62bdb3f43

34390-5

Set id: 36ba13a4-4046-4dae-ab66-744bb8ff973d

Version: 4

Effective Time: 20241125