| NDC Code | 0067-0112-01 |
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| Package Description | 20 TABLET, CHEWABLE in 1 BOTTLE (0067-0112-01) |
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| Product NDC | 0067-0112 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Theraflu |
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| Proprietary Name Suffix | Severe Cold Relief Nighttime Soft Chews |
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| Non-Proprietary Name | Acetaminophen, Diphenhydramine Hcl |
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| Dosage Form | TABLET, CHEWABLE |
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| Usage | ORAL |
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| Start Marketing Date | 20240930 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M012 |
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| Manufacturer | Haleon US Holdings LLC |
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| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE |
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| Strength | 325; 12.5 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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