Active Ingredient(S)
Guaifenesin, USP 200 mg
Tussin Solution
FDA Label NDC 70677-1186
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services for the product Tussin (NDC 70677-1186). 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(s), purpose, use(s), ask a doctor before use if you have, when using this product, stop use and ask doctor if, if pregnant or breast-feeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Expectorant
Use(S)
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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
When Using This Product
■ do not use more than directed
Stop Use And Ask Doctor If
■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
■ do not take more than 6 doses in any 24-hour period.
■ this adult strength product is not intended for use in children under 12 years of age
■ mL = milliliter
■ measure only with dosing cup provided
■ keep dosing cup with product
| Age | Dose |
| Adults and children
12 years and over | 10 – 20 mL
every 4 hours |
| Children under 12 years
| do not use
|
Other Information
■
each 10 mL contains:sodium 6 mg
■ store between 20-25°C (68-77°F)
■ do not refrigerate
■
Keep carton for full directions for use
Inactive Ingredients
Caramel, citric acid anhydrous, dextrose, FD&C red #40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate
Questions Or Comments?
Call 833-358-6431Monday to Friday 9:00am to 7:00pm EST
Principal Display Panel
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