DOLOFIN- acetaminophen tablet

Dolofin by

Drug Labeling and Warnings

Dolofin 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:

Alcohol warning:

• if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Liver warning:

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

• more than 6 tablets in 24 hours, which is the maximum daily amount
• 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.
• for more than 10 days for pain, unless directed by a doctor.
• for more than 3 days for fever, unless directed by a doctor. 

Ask a doctor before use 

• if you have liver disease
• if you are taking the blood thinning drug warfarin.

Stop using this product and ask a doctor if:

• symptoms do not improve
• pain or fever persists or get worse
• New symptoms occur
• Redness or swelling is present
• These could be signs of a serious condition

PREGNANCY OR BREAST FEEDING

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the 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 6 tablets in 24 hours

• Adults and children12 years and over: Take 1 tablet every 4-6 hours as needed, or as directed by a doctor.
• Children under 12 years: Do not use this adult extra strength product in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminophen and could cause liver damage.

INACTIVE INGREDIENT

Inactive ingredients Dicalcium phosphate, microcrystalline cellulose, povidone, silicon dioxide, sodium carboxy methyl starch, stearic acid, talc

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOLOFIN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-420
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

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: 53145-420-30	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(53145-420)