Dolo-neurobion Tablet, Film Coated
FDA Label NDC 55959-131
11 label sections · Submitted to the FDA by Benard Industries Inc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Benard Industries Inc for the product Dolo-neurobion (NDC 55959-131). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
temporarily relieves minor aches and pains due to:
• headache • muscular aches • minor pain of arthritis • backache • the common cold • toothache • premenstrual and menstrual cramps
temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 4,000 mg in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • 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.
Otc - 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.
Directions
• do not use 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
• store at room temperature 59°-86°F (15°-30°C)
• TAMPER EVIDENT child resistant packets
• do not use any opened or torn packets
Inactive Ingredients
corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Questions Or Comments?
305.594.0480
Packaging
Doloneurobion (55959131 2)
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