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  5. Label Information: Dextromethorphan Hbr 15 Mg

FDA Label for Dextromethorphan Hbr 15 Mg

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF THE USER HAS
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS?
    10. PRINCIPAL DISPLAY PANEL - SHIPPING LABEL

Dextromethorphan Hbr 15 Mg Product Label

The following document was submitted to the FDA by the labeler of this product Humanwell Puracap Pharmaceuticals (wuhan) Co., Ltd.. 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.

Active Ingredient (In Each Softgel)



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


Warnings




Ask A Doctor Before Use If The User Has



  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

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 of age and over

         take 2 capsules every 6 to 8 hours, as  needed

    children under 12 years of  age

         do 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 #1, FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Wuhan, Hubei
430206, China


Questions Or Comments?



Call toll free 1-855-215-8180


Principal Display Panel - Shipping Label



Dextromethorphan HBr Capsules, 15 mg

Quantity : 12000 Capsules
NDC No. : 53345-028-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"


* Please review the disclaimer below.