Dextromethorphan Hydrobromide
FDA Label NDC 59105-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by J.p. Business Enterprise for the product Dextromethorphan Hydrobromide (NDC 59105-006). 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 other, active ingredient (in each liquid-filled capsule), purpose, use, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed By: J.P Business Enterprise
Lake Grove, NY 11755

Active Ingredient (In Each Liquid-Filled Capsule)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Otc - Do Not Use

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Ask Doctor

Ask a doctor before use if you have

  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema
  • trouble urinating due to an enlarged prostate gland

Otc - Stop Use

Stop use and ask doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than 8 capsules in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
    • adults and children 12 years and overtake 2 capsules every 6 to 8 hours, as needed
    children under 12 yearsdo not use

Other Information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light

Inactive Ingredients

FD&C blue no. 1, FD&C red no. 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments?

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Principal Display Panel - 15 Softgel Bottle Carton

VALUMEDS

Compare to the Active Ingredient of
ROBITUSSIN ® LONG-ACTING COUGHGELS ®*

ADULT LONG-LASTING
COUGH RELIEF
FOR AGES
12 & Over

DEXTROMETHORPHAN HBr, USP 15 mg

COUGH SUPPRESSANT

  • Relieves cough for up to 8 hours
  • Non- Drowsy
  • Non-Narcotic Formula

    • 15 SOFTGELS**
    **Liquid Filled Capsules

    Principal Display Panel (15 Softgel Bottle Carton)

    Principal Display Panel (15 Softgel Bottle Carton)

* Please review the disclaimer below.