ACETAMINOPHEN- acetaminophen tablet 
Velocity Pharma LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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

do not use

ask a doctor before use if you have liver disease

ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if:

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than 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

Other Information

Inactive Ingredients

P.G Starch, P.V.P.K.30, sodium metabisulfite, colloidal silicon dioxide, Hypromellose-15, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Sodium Starch Glycolate, Hypromellose-6, Polyethylene Glycol, Titanium Dioxide.

Questions or Comments

Questions? 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

APAP 60

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-120
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code P500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-120-1060 in 1 BOTTLE05/14/2018
11 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/14/2018
Labeler - Velocity Pharma LLC (962198409)

Revised: 5/2018
Document Id: 6c311047-4be7-44ad-e053-2a91aa0ad047
Set id: bba2ddc5-19e0-4f11-8ff7-7dd7c2d53b50
Version: 2
Effective Time: 20180514
 
Velocity Pharma LLC