FDA Label for Gadavyt Cough
View Indications, Usage & Precautions
Gadavyt Cough Product Label
The following document was submitted to the FDA by the labeler of this product Gadal Laboratories Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient (in each 5 mL tsp.) Purpose
Guaifenesin 100mg Expectorant
Otc - Purpose
USES
Helps loosen phlegm (mucus) and thin bronchial
secretions to make coughs more productive
Warnings
Warnings
Ask a doctor before use if
- you have cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.
- cough occurs with too much phlegm (mucus)
Otc - Do Not Use
Stop use and ask a doctor if
- cough lasts for more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of
overdose, get medical help or contact a Poison Control Center
right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional
before use.
Dosage & Administration
Directions
do not take more than 6 doses in any 24 hour period
| adults and children 12 years and over | 2-4 TSP every 4 hours or as directed by doctor |
| children under 12 years | do not use |
Indications & Usage
Other information
store at room temperature 15 - 30 degrees C (59 - 86 degrees F)
TAMPER-EVIDENT: Do not use if seal under cap is torn,
broken or missing.
Inactive Ingredient
Inactive Ingredients
Citric acid, menthol, methylparaben, propylparaben, glycerin,
sucralose, sodium citrate, FD and C Red No. 40, caramel color,
cherry flavor, natrosol, purified water.
Otc - Questions
GADAL Laboratories, Inc.
Miami, Fl 33186
www.gadallaboratories.com
Package Label.Principal Display Panel
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