Label: DOLO- NEUROBION ACETAMINOPHEN 500MG- acetaminophen tablet, film coated
- NDC Code(s): 55959-171-03, 55959-171-06
- Packager: BENARD INDUSTRIES 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 September 7, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient (per tablet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take
• more than 8 tablets in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reaction.
Symptoms may include: • skin reddening • blister • rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
• with any other drug containing acetaminophen (prescription or nonprescription). 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 this product
Ask a doctor before use if you have liver disease.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop use 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 present
These could be signs of a serious condition
If pregnant or breast-feeding, ask a health professional before use.
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Directions
• do not take more than directed (see overdose warning)
Adults and children 12 years and over • take 2 tablets every 6 hours while symptoms last.
• do not take more than 6 tablets in 24 hours, unless directed by a doctor.
• do not use for more than 10 days unless directed by a doctor
children under 12 years ask a doctor
- Other information
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Inactive ingredients:
croscarmellose sodium, dicalcium phosphate, FD&C yellow #5 lake*, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stearic acid, talc, titanium dioxide.
*This product contains FD&C Yellow #5 Lake (Tartrazine) as a color additive.
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INGREDIENTS AND APPEARANCE
DOLO- NEUROBION ACETAMINOPHEN 500MG
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55959-171 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color yellow Score no score Shape ROUND Size 13mm Flavor Imprint Code DOLO;N Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55959-171-03 1 in 1 CARTON 05/04/2016 1 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:55959-171-06 1 in 1 CARTON 05/04/2016 2 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/04/2016 Labeler - BENARD INDUSTRIES INC (106700321)
