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  5. Label Information: Dextromethorphan Hydrobromide

FDA Label for Dextromethorphan Hydrobromide

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH LIQUID-FILLED CAPSULE)
    3. PURPOSE
    4. USE
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 15 SOFTGEL BOTTLE CARTON

Dextromethorphan Hydrobromide Product Label

The following document was submitted to the FDA by the labeler of this product J.p. Business Enterprise. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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?



1-888-333-9792


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

* Please review the disclaimer below.