DURALGINA- acetaminophen tablet

Duralgina by

Drug Labeling and Warnings

Duralgina by is a Otc medication manufactured, distributed, or labeled by Menper Distributors Inc., Lex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each tablet)

Acetaminophen 325 mg

PURPOSE

Purpose

Pain reliever/Fever reducer

INDICATIONS & USAGE

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

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

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

KEEP OUT OF REACH OF CHILDREN

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.

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

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DURALGINA 
acetaminophen tablet

Product 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)