FDA Label for Dextromethorphan Hydrobromide
View Indications, Usage & Precautions
Dextromethorphan Hydrobromide Product Label
The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals,llc. 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 Ingredients (In Each Liquicap)
Dextromethorphan Hbr 15 mg
Purpose
Cough Suppressant
Uses Temporarily
relieves cough due to minor throat and bronchial irritation may occur with a cold
Overdose Warning
In case of overdose,get medical help or contact a poison control center right away.
Direction
* do not take more than 8 liquidgels in any 24 hour period.* adults and children 12 years over : take 2 liquidgels every 6 to 8 hours, as needed* Children under 12years: ask a doctor
Other Information
* each tablet contains : Store at room temperature
Inactive Ingredients
FD &C Red No 40 IH, Polyethylene Glycol , Gelatin, Glycerin, Povidone, Purified water, Sorbitol
Principal Display Panel - 15Mg Tablet Shipper Label
Dextromethorphan Hydrobromide Soft Gelatin Capsules
Each Soft Gelatin Capsules Contains:
Dextromethorphan Hydrobromide USP 15mg
Lot No. :
Mfg. Date :
Exp. Date :
NDC No. : 68210-1530-4
Quantity : 4000 Capsules
Gross Wt. :
WARNING :
KEEP OUT OF THE REACH OF CHILDREN
STORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FDAAND REGULATIONS THEREUNDER
MANUFACTURED BY:
Marksans Pharma Ltd
Verna, GOA-403722,
India.
Code : GO/DRUGS/515
MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS,LLC
225 LINCOLN HWY, STE # 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000; FAX.#2159434039
OMIL059
CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
* Please review the disclaimer below.