Active Ingredient (Per Teaspoonful = 5Ml)
Guaifenesin, USP 100 mg
Geri-tussin Expectorant
FDA Label NDC 17856-0793
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corps for the product Geri-tussin Expectorant (NDC 17856-0793). 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 active ingredient (per teaspoonful = 5ml), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, 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 make coughs more productive
Warnings
Do not use if you are hypersensitive to any of the ingredients
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, or emphysema
Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than 6 doses in any 24-hour period
- do not exceed recommended dose
| adults and children 12 years and over | 2-4 teaspoonfuls every 4 hours |
| children under 12 years | ask a doctor |
Other Information
• store at room temperature 15° - 30°C (59° - 86°F)
• protect from freezing
• protect from light
• TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING
Inactive Ingredients
citric acid, caramel, FD and C Red 40, flavor, glycerin, menthol, sodium saccharin, sodium benzoate, sorbitol, water
How Supplied
Product: 17856-0793
NDC: 17856-0793-1 15 mL in a CUP, UNIT-DOSE
NDC: 17856-0793-2 10 mL in a CUP, UNIT-DOSE
NDC: 17856-0793-3 5 mL in a CUP, UNIT-DOSE
Geri-Tussin Expectorant (Guaifenesin) Liquid
NDC 17856-0793-1
NDC 17856-0793-2
NDC 17856-0793-03
* Please review the disclaimer below.
