Label: 999 COLD REMEDY GRANULAR- acetaminophen, chlorpheniramine maleate granule
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Contains inactivated NDC Code(s)
NDC Code(s): 12753-307-02 - Packager: China Resources Sanjiu Medical & Pharmaceutical Co Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 September 24, 2013
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- Active Ingredients
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INGREDIENTS AND APPEARANCE
999 COLD REMEDY GRANULAR
acetaminophen, chlorpheniramine maleate granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12753-307 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) Acetaminophen 200 mg in 90 g Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) Chlorpheniramine Maleate 4 mg in 90 g Inactive Ingredients Ingredient Name Strength Caffeine (UNII: 3G6A5W338E) MELICOPE PTELEIFOLIA LEAF (UNII: 1I20C6Y98I) Bidens Pilosa Whole (UNII: AYT02NS64S) Dendranthema indicum flower (UNII: I6OER6U04L) ilex Pedunculosa whole (UNII: 46804GL8SN) Product Characteristics Color white Score 2 pieces Shape SQUARE Size 20mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12753-307-02 10 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/03/2003 Labeler - China Resources Sanjiu Medical & Pharmaceutical Co Ltd (544695711) Registrant - China Resources Sanjiu Medical & Pharmaceutical Co Ltd (544695711) Establishment Name Address ID/FEI Business Operations China Resources Sanjiu Medical & Pharmaceutical Co Ltd 544695711 manufacture(12753-307)