Label: DEXTROMETHORPHAN HYDROBROMIDE capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 68210-1530-1, 68210-1530-4, 68210-1530-6, 68210-1530-8 - Packager: SPIRIT PHARMACEUTICALS,LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 26, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each LiquiCap)
- Purpose
- Uses temporarily
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Warnings
Do not use
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- 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.
Ask a doctor before use if you have
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- a cough that occurs with too much phlegm(mucus)
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- a cough that lasts or is chronic cough as occurs with smoking, asthma or emphysema
- Direction
- Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - 15mg Tablet Shipper Label
Dextromethorphan Hydrobromide Soft Gelatin Capsules
Each Soft Gelatin Capsules Contains:
Dextromethorphan Hydrobromide USP 15mgLot No. :
Mfg. Date :
Exp. Date :
NDC No. : 68210-1530-4
Quantity : 4000 Capsules
Gross Wt. :
WARNING :
KEEP OUT OF THE REACH OF CHILDRENSTORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZINGTHIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FDAAND REGULATIONS THEREUNDERMANUFACTURED BY:
Marksans Pharma Ltd
Verna, GOA-403722,
India.
Code : GO/DRUGS/515MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS,LLC
225 LINCOLN HWY, STE # 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000; FAX.#2159434039OMIL059
CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
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INGREDIENTS AND APPEARANCE
DEXTROMETHORPHAN HYDROBROMIDE
dextromethorphan hydrobromide capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-1530 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GELATIN (UNII: 2G86QN327L) POVIDONE (UNII: FZ989GH94E) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color RED Score no score Shape OVAL Size 15mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-1530-4 1 in 1 DRUM 1 4000 in 1 BAG 2 NDC:68210-1530-6 1 in 1 DRUM 2 6000 in 1 BAG 3 NDC:68210-1530-8 1 in 1 DRUM 3 8000 in 1 BAG 4 NDC:68210-1530-1 1 in 1 DRUM 4 10000 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/15/2010 Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)