| NDC Code | 50991-510-02 |
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| Package Description | 12 BLISTER PACK in 1 CARTON (50991-510-02) > 1 TABLET, FILM COATED in 1 BLISTER PACK |
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| Product NDC | 50991-510 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Duraflu |
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| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Pseudoephedrine Hcl |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20110210 |
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| Marketing Category Name | OTC MONOGRAPH FINAL |
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| Application Number | part341 |
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| Manufacturer | Poly Pharmaceuticals, Inc. |
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| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
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| Strength | 500; 20; 200; 60 |
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| Strength Unit | mg/1; mg/1; mg/1; mg/1 |
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