FDA Label for Gadavyt Cough DM
View Indications, Usage & Precautions
Gadavyt Cough DM 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
Dextromethorphan HBr Cough Suppressant
Guaifenesin 100mg Expectorant
Otc - Purpose
USES
- temporarily quiets cough associated with the common cold or inhaled irritants
- 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
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression,
psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not
know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.
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 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, methylparaben, propylparaben,glycerin, sucralose,
sodium citrate, FD and C Red No. 40, menthol, natrosol, cherry flavor,
purified water
Otc - Questions
GADAL Laboratories, Inc.
Miami, Fl 33186
www.gadallaboratories.com
Package Label.Principal Display Panel
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