Application Nr Approved Date Route Status External Links
ANDA091671 2012-06-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Hydrocodone Polistirex And Chlorpheniramine Polistirex Extended-Release Oral Suspension Is Indicated For Relief Of Cough And Upper Respiratory Symptoms Associated With Allergy Or A Cold In Adults And Children 6 Years Of Age And Older.

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Water WATER Molecular
2. High Fructose Corn Syrup HIGH FRUCTOSE CORN SYRUP Unresolved
3. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
4. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Xanthan Gum XANTHAN GUM Unresolved EMUL-Emulsifier FS-Substances permitted as optional ingredient in a standardized food.
6. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
7. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
8. Ascorbic Acid ASCORBIC ACID Molecular DS-Dietary supplement , MISC-Miscellaneous , NUTR-Nutrient , PRES-Chemical preservative FS-Substances permitted as optional ingredient in a standardized food.
9. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
10. Ethylcelluloses ETHYLCELLULOSES Unresolved
11. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
12. Dibutyl Sebacate DIBUTYL SEBACATE Molecular

Active Ingredients ( 2 Total)

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