Acetaminophen, Dextromethorphan Hbr Capsule, Liquid Filled
FDA Label NDC 84324-036

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Acetaminophen, Dextromethorphan Hbr (NDC 84324-036). 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 active ingredients (in each softgel), purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Softgel)

Acetaminophen 325 mg ........................................ Pain reliever/fever reducer

Dextromethorphan HBr 10 mg ......................... Cough suppressant

Purpose

Acetaminophen 325 mg ........................................ Pain reliever/fever reducer

Dextromethorphan HBr 10 mg ......................... Cough suppressant

Uses

Temporarily relieves common cold and flu symptoms:
• Minor aches and pains
• Headache
• Sore throat
• Fever
• Cough due to minor throat and bronchial irritation

Warnings

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.

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:
• More than 8 softgels in 24 hours, which is the maximum daily amount for this product
• With other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

Take only as directed-see OVERDOSE WARNING.
Do not exceed 8 softgels per 24 hours.

 Adults & children 12 years and over Take 2 softgels with water every 4 hours
 Children 4 to under 12 years Ask a doctor
 Children under 4 years Do not use

Other Information

• Store at room temperature between 20°–25°C (68°–77°F).
• Avoid excessive heat, cold, and humidity.

Inactive Ingredients

Polyethylene Glycol-400, Propylene Glycol, Povidone (PVPK-30), FD & C Red No. 40, FD & C Yellow No. 6, Purified Water, Gelatin, Glycerin, Sorbitol Sorbitan Solution.

* Please review the disclaimer below.