Application Nr Approved Date Route Status External Links
ANDA206891 2017-06-09 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Hydrocodone Bitartrate And Chlorpheniramine Maleate Oral Solution Is A Combination Of Hydrocodone Bitartrate, An Antitussive, And Chlorpheniramine Maleate, A Histamine-1 (h 1) Receptor Antagonist, Indicated For Relief Of Cough And Symptoms Associated With Upper Respiratory Allergies Or A Common Cold ( 1.1) Limitations Of Use: Not Indicated For Pediatric Patients Under 18 Years Of Age ( 1.1) 1.1 Cough And Upper Respiratory Allergy Symptoms Hydrocodone Bitartrate And Chlorpheniramine Maleate Oral Solution Is Indicated For Relief Of Cough And Symptoms Associated With Upper Respiratory Allergies Or A Common Cold In Adults 18 Years Of Age And Older. Important Limitations Of Use Not Indicated For Pediatric Patients Under 18 Years Of Age [see Use In Specific Populations ( 8.4)] .

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
2. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
3. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
5. Water WATER Molecular
6. Sodium Citrate, Unspecified Form SODIUM CITRATE, UNSPECIFIED FORM Molecular
7. Saccharin Sodium SACCHARIN SODIUM Molecular

Active Ingredients ( 2 Total)

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