Label: DEXTROMETHORPHAN HYDROBROMIDE capsule, liquid filled
- NDC Code(s): 68210-0106-1, 68210-0106-2
- Packager: Spirit Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 7, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each softgel)
- 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DEXTROMETHORPHAN HYDROBROMIDE
dextromethorphan hydrobromide capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0106 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) GLYCERIN (UNII: PDC6A3C0OX) GELATIN (UNII: 2G86QN327L) SORBITOL (UNII: 506T60A25R) FD&C RED NO. 40 (UNII: WZB9127XOA) 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:68210-0106-1 1 in 1 CARTON 04/10/2018 1 15 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:68210-0106-2 1 in 1 CARTON 03/12/2020 2 240 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 Drug M012 04/10/2018 Labeler - Spirit Pharmaceuticals LLC (179621011)