Acetaminophen by Prostat First Aid ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Prostat First Aid. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Acetaminophen USP, 325mg (in each tablet)

Purpose

Pain Releiver / Fever Reducer

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.

Uses

Temporarily relieves minor aches and pains due to

Common cold

headache

minor pain of arthritis

toothache

muscular aches

premenstrual and menstrual cramps

temporarily relieves fever

Warnings

Liver warning

This product contains acetaminophen.

The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if:

• adutls take more than 4000mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours, which is the maximum daily amount.
• 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 ad seek medical medical help right away

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.

Keep out of reach of children

Keep out of reach of children, 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 and children 12 years and older

• Take 2 tablets every 4 to 6 hours while symptoms last
• Do not take more than 10 tablets in 24 hours unless directed by a doctor
• Do not use for more than 10 days unless directed by a doctor

Children 6 years to under 12 years:

• take 1 tablet every 4 to 6 hours while symptoms last
• do not take more than 5 tablets in 24 hours
• do not use for more than 5 days unless directed by a doctor

Children under 6 years of age:

• Ask a doctor

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 a sign of a serious condition

If pregnant or breast-feeding

Ask a health professional before use

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 cretical for adults as well as children even if you do not notice symptoms.

Other Information

• Store at 20ºC - 25ºC (68ºF - 77ºF)

Inactive Ingredients

hydroxypropyl methyl cellulose, polyethylene glycol, povidone K-30, Pregelatinized starch, Sodium starch glycoate, Stearic Acid

Questions or Comments?

Call 1-888-900-2920

Distributed By:

Distributed By:

ProStat First Aid

La Verne, CA. 91750 USA

*This product is not manufactured or distributed by the Johnson & Johnson Corporation, owner of the registered trademark Tylenol®

Made in the USA

Label

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58228-0061
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POVIDONE K30 (UNII: U725QWY32X)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	G323
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58228-0061-1	10000 in 1 BAG	08/06/2025
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	08/06/2025

Labeler - Prostat First Aid (061263699)