| NDC Code | 69365-003-02 |
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| Package Description | 1 BLISTER PACK in 1 CARTON (69365-003-02) > 1 CAPSULE in 1 BLISTER PACK > 10 CAPSULE, LIQUID FILLED in 1 CAPSULE |
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| Product NDC | 69365-003 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Facol Cold And Flu Night |
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| Non-Proprietary Name | Acetaminophen, Guaifenesin, Phenylephrine Hcl, Dextromethorphan Hbr, Diphenhydramine Hcl |
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| Dosage Form | CAPSULE, LIQUID FILLED |
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| Usage | ORAL |
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| Start Marketing Date | 20150801 |
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| Marketing Category Name | OTC MONOGRAPH NOT FINAL |
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| Application Number | part343 |
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| Manufacturer | JW HOLDINGS |
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| Substance Name | ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE |
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| Strength | 200; 35; 5; 8; 18.75 |
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| Strength Unit | mg/1; mg/1; mg/1; mg/1; mg/1 |
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