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Acetaminophen by Velocity Pharma

Medically reviewed on August 27, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Velocity Pharma
NDC Code: 76168-010

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
  • temporarily reduces fever

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product

do not use

  • with any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • If you have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.

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:

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms appear

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 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
  • do not take more than directed (see overdose warning).
  • Adults and children 12 years and over:
  • take 2 caplets every 6 hours while symptoms last.
  • do not take more than 6 caplets of this product in 24 hours, unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor

    children under 12 years:

  • Ask a doctor

Other Information
  • Store at a controlled temperature between  62° and 77 °F)

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

NDC: 76168-010 -12 100 COUNT

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-010
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
POVIDONE K30 
SODIUM METABISULFITE 
SILICON DIOXIDE 
HYPROMELLOSE 2910 (15 MPA.S) 
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
HYPROMELLOSE 2910 (6 MPA.S) 
POLYETHYLENE GLYCOL 1000 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeBH
Contains    
Packaging
#Item CodePackage Description
1NDC:76168-010-12100 CARTON (TABLET) in 1 BOTTLE
11 TABLET (BOTTLE) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/05/2012
Labeler - Velocity Pharma (962198409)

 
Velocity Pharma

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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