- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
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 INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DURALGINA
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53145-013 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code 555 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53145-013-71 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/01/2017 Labeler - Menper Distributors Inc. (101947166) Registrant - Menper Distributors Inc. (101947166) Establishment Name Address ID/FEI Business Operations Lex Inc. 046172888 manufacture(53145-013)