Label: DOLOFIN- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 53145-420-30 - Packager: Menper Distributors Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 24, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- KEEP OUT OF REACH OF CHILDREN
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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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOLOFIN
acetaminophen tabletProduct 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)
