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Duralgina

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: Menper Distributors Inc.
NDC code: 53145-013

Medically reviewed by Drugs.com. Last updated on Oct 16, 2023.

Active Ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/Fever reducer

Uses

For the temporary relief of minor aches and pains associated with 

  • headache
  • muscular aches
  • minor arthritis pain
  • menstrual cramps
  • common cold
  • temporarily reduces fever
  • backaches
  • toothaches

Warnings:

Liver warning:

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

  • more than12 tablets in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day.

Do not use:

  • with any other drug conatining acetaminophen (prescription or non-prescription). 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 the product.

Ask a doctor before use if you have liver disease

Ask a docor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop using this product 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 persistent
  • 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 children12 years and over Take 2 tablets every 4-6 hours as needed. Do not take more than 12 tablets in 24 hours, unless directed by a doctor
 Children ages 6-11 Take 1 tablet every 4-6 hours as needed. Do not take more than 6 tablets in 24 hours, unless directed by a doctor
 Under 6 years of age Ask a doctor

Inactive ingredients Magnesium stearate, povidone, silicone dioxide, sodium carboxymethyl, starch, stearic acid

Questions: Call 1-800-560-5223 M-F 9AM - 4PM Eastern

DURALGINA 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-013
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
POVIDONE 
SILICON DIOXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
STARCH, CORN 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code555
Contains    
Packaging
#Item CodePackage Description
1NDC:53145-013-7130 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/01/2017
Labeler - Menper Distributors Inc. (101947166)
Registrant - Menper Distributors Inc. (101947166)
Establishment
NameAddressID/FEIOperations
Lex Inc.046172888manufacture(53145-013)

Revised: 10/2017
 
Menper Distributors Inc.

Further information

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