Otc - Active Ingredient
Active Ingredients:(in each teaspoonful 5 ml.) Purpose
Guaifenesin 200 mg ................................................................... Expectorant
Guaifed Liquid
FDA Label NDC 73564-801
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aldama Pharmaceuticals, Inc for the product Guaifed (NDC 73564-801). 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 - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Expectorant
Indications & Usage
Uses:
- Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus.
Warnings
Warnings
- Do not use: if you ever had an allergic reaction to any of the ingredients in this product
- cough that occurs with too much phlegm (mucus)
- cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor before use if you have
Otc - Stop Use
Stop use and ask a doctor if
- cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
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.
Dosage & Administration
Directions
- take every 4 hours as needed, or as directed by doctor
- do not take more than 6 doses in 24 hours
- do not exceed recommended dosage
| Age | Dose |
| adults and children 12 years and over | 10 mL to 20 mL (2 to 4 teaspoonfuls) |
| children under 12 years of age | ask a doctor |
Other Safety Information
Other information
- each 10 mL contains:potassium 20 mg
- TAMPER - EVIDENT FEATURE:Do not use if foil seal over bottle opening is torn, broken or missing.
- store between 15° - 30°C (59° - 86°F). Protect from freezing
- protect from light
Inactive Ingredient
Inactive Ingredients:
Artificial and natural cherry flavor, citric acid, menthol, Methylparaben, Propylene glycol, Propylparaben, purified water, sodium citrate, sucralose
Otc - Questions
Questions or Comments? 305-592-9216 or [email protected]
* Please review the disclaimer below.
