Acetaminophen by Trifecta Pharmaceuticals USA LLC ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each caplet)

Acetaminophen USP, 500mg

Purpose

Pain Reliever / 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

The Common cold

headache

Backache

minor pain of arthritis

toothache

muscular aches

premenstrual and menstrual cramps

temporarily relieves fever

Warnings

Liver warning

This product contains acetaminophen. Sever liver damage may occur if you take

• more than 4000mg 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 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

Directions

Do not take more than directed. See overdose warning

Adults and children 12 years and older

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

Other Information

• Store at 20ºC - 25ºC (68ºF - 77ºF). See USP controlled room temperature
• Avoid high humidity
• See end panel for expiration date and lot number
• Tamper Evident. Do not use if imprinted safety seal under cap is broken or missing
• Important. Read the directions and warnings before use

Inactive Ingredients

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

Questions or Comments?

Call 1-888-296-9067

Distributed By:

Distributed By:

Trifecta Pharmaceuticals USA®

Ft. Lauderdale, FL. 33301 USA

1-888-296-9067

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

Made in the USA

Package Label

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-144
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
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE K30 (UNII: U725QWY32X)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Product Characteristics
Color	white (White to Off-White)	Score	no score
Shape	CAPSULE (Caplet Shape)	Size	17mm
Flavor		Imprint Code	G551
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-144-01	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/07/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	08/08/2023

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)