EXTRA STRENGHTH ACETAMINOPHEN- acetaminophen tablet 
Health Pharma USA LLC

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Acetaminophen Extra Strength 500 mg

Active Ingredient

(in each tablet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning:This product contains acetaminophen. Severe 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 and seek medical help right away.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

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 reccomended dose (overdose) may cause liver damage. In case of overdose. get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dosage.

Directions

Other Information

Inactive Ingredients

Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Polyethylene Glycol, Polyvinyl Pyrolidone, Stearic Acid, Talc, Titanium Dioxide

Questions or Comments

Call toll free 1-844-832-1138 Monday through Friday 9AM-5PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

APAP 500 mg Caplets-AP 500Extra Strength Pain Reliever 500mg Caplets

NDC 71679-107-05

Count: 500

EXTRA STRENGHTH ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71679-107
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code AP;500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71679-107-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01301/27/2022
Labeler - Health Pharma USA LLC (080804485)
Establishment
NameAddressID/FEIBusiness Operations
Health Pharma USA LLC080804485manufacture(71679-107)

Revised: 10/2023
Document Id: 08d62962-a646-de73-e063-6394a90a7c46
Set id: d6952c44-c525-2257-e053-2a95a90abfea
Version: 4
Effective Time: 20231021
 
Health Pharma USA LLC