ACETAMINOPHEN by Akron Pharma Inc. ACETAMINOPHEN tablet

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]

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
• is a child with pain of arthritis

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 & children12 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
• children under 12 years:
  • ask a doctor

Other information

• store at 20° to 25°C (68° to 77°F)

Inactive Ingredients:

Gelatinized starch, magnesium stearate, povidone

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-1026
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, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	5mm
Flavor		Imprint Code	A500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-1026-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2024
2	NDC: 71399-1026-2	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	12/06/2024

Labeler - Akron Pharma Inc. (067878881)