Otc - Purpose
FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING
Guaifenesin And Dextromethorphan Hydrobromide Tablet
FDA Label NDC 57631-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Invatech Pharma Solutions Llc for the product Guaifenesin And Dextromethorphan Hydrobromide (NDC 57631-013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, otc - keep out of reach of children, indications & usage, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
KEEP OUT OF THE REACH OF CHILDREN
Indications & Usage
cough cold, allergic
Warnings
KEEP OUT OF THE REACH OF CHILDREN,FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING
Inactive Ingredient
Colloidal Silicon Di oxide USP/NF, Hypromellose 5 [ Hydroxy propyl methyl cellulose - E5] USP, Hypromellose 15 Hydroxy propyl methylcellulose E-15 USP, Magnesium stearate. USP/NF, Maltodextrin USP/NF, Microcrystalline cellulose (PH-102) USP/NF, Polyethylene glycol 400 USP/NF, Polyvinyl pyrrolidone (PVPK 30) USP, Sodium starch glycolate Type-A USP/NF, Stearic acid powder
Package Label.Principal Display Panel
Label (917 01 1)
* Please review the disclaimer below.
