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Extra Strength Acetaminophen by PuraCap Pharmaceutical LLC

Medically reviewed on November 9, 2017

Dosage form: tablet, film coated
Ingredients: Acetaminophen 500mg
Labeler: PuraCap Pharmaceutical LLC
NDC Code: 51013-320

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.

Extra Strength Acetaminophen Tablets

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

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 reduces fever

Warnings

Liver warning

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

  • more than 4,000 mg 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 and seek medical help right away.

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

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

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 signs of a serious condition.

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

Keep out of reach of children.

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 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 in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 yearsask a doctor

Other information
  • Store the product at controlled room temperature 15°-30°C (59°-86°F).
  • Protect from light, moisture and freezing.

Inactive ingredients

hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, pregelatinized starch, stearic acid powder, talc, titanium dioxide

Questions or comments?

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

CVS Extra Strength Acetaminophen Tablets, 500 mg

NDC 51013-320-54

EXTRA STRENGTH ACETAMINOPHEN 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-320
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, PREGELATINIZED CORN 
POVIDONE 
hypromellose, unspecified 
magnesium stearate 
polyethylene glycol, unspecified 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
TALC 
titanium dioxide 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize13mm
FlavorImprint CodeB;H
Contains    
Packaging
#Item CodePackage Description
1NDC:51013-320-5415 POUCH in 1 CARTON
12 TABLET, FILM COATED in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34311/09/2017
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIOperations
ELYSIUM PHARMACEUTICALS LIMITED915664486manufacture(51013-320)

 
PuraCap Pharmaceutical LLC

← See all Extra Strength Acetaminophen brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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