ACETAMINOPHEN- acetaminophen tablet 
Trifecta Pharmaceuticals USA LLC

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Acetaminophen 500mg

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

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include

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

Children under 12 years of age

Stop Use and ask a doctor if

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

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

globe acetaminophen caplet CDER

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-144
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (White to Off-White) Scoreno score
ShapeCAPSULE (Caplet Shape) Size17mm
FlavorImprint Code G551
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-144-011000 in 1 BOTTLE; Type 0: Not a Combination Product11/07/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01308/08/2023
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 11/2023
Document Id: 09935a81-941d-1499-e063-6294a90a049c
Set id: 09935a74-34b0-0e7c-e063-6294a90a7c83
Version: 1
Effective Time: 20231107
 
Trifecta Pharmaceuticals USA LLC