Label: DEXTROMETHORPHAN HYDROBROMIDE capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 59105-006-15 - Packager: J.P. BUSINESS ENTERPRISE
- 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 December 26, 2019
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 ingredient (in each liquid-filled capsule)
- Purpose
- Use
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Warnings
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.
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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 Softgel Bottle Carton
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INGREDIENTS AND APPEARANCE
DEXTROMETHORPHAN HYDROBROMIDE
dextromethorphan hydrobromide capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59105-006 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) POVIDONE K30 (UNII: U725QWY32X) WATER (UNII: 059QF0KO0R) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape OVAL Size 13mm Flavor Imprint Code 404 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59105-006-15 1 in 1 CARTON 12/01/2014 1 15 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/01/2014 Labeler - J.P. BUSINESS ENTERPRISE (078775890) Establishment Name Address ID/FEI Business Operations MEDGEL PVT LTD 677385498 manufacture(59105-006)