Drug Facts
Active ingredient (in each 5 mL teaspoonful)
Guaifenesin, USP 100 mg
Guaifenesin Liquid
FDA Label NDC 81033-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kesin Pharma Corporation for the product Guaifenesin (NDC 81033-102). 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 drug facts, purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Expectorant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
Do Not Use
- if you ever had an allergic reaction to any of the ingredients in this product
Ask A Doctor Before Use If You Have
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic, bronchitis, emphysema
Stop Use And Ask A Doctor If
cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take every 4 hours, as needed, or directed by a doctor
- do not take more than 6 doses in 24 hours
- do not exceed recommended dose
| Age | Dose |
| adults and children 12 years and over | 2 to 4 tespoonfuls every 4 hours |
| children 6 years to under 12 years | 1 to 2 teaspoonfuls every 4 hours |
| children 2 years to under 6 years | 1/2 to 1 teaspoonful every 4 hours |
| under 2 years | ask a doctor |
Other Information
- store at 20°C to 25°C (68°F to 77°F). Protect from light.
- do not refrigerate
- Do not use this product of printed inner seal is broken or missing
Inactive Ingredients
citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose
Questions Or Comments?
1-833-537-4679
Other
*This product is not manufactured or distributed by the owner of registered trademark of Robitussin ®.
Distributed by:
Kesin Pharma
Oldsmar, FL 34677
Revision 03/2025
Package Label.Principal Display Panel
NDC 81033-102-16
Guaifenesin Oral Solution, USP
100 mg/5 mL
Expectorant
Grape Flavor
16 fl oz (473 mL)
* Please review the disclaimer below.
