FDA Label for Libera Tos
View Indications, Usage & Precautions
Libera Tos Product Label
The following document was submitted to the FDA by the labeler of this product Rockhealth, 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 Ingredients:(in each teaspoonful 5 ml.) Purpose
Dextromethorphan Hydrobromide 10 mg .................................... Cough Suppressant
Guaifenesin 100 mg ................................................................... Expectorant
Otc - Purpose
Uses:
- Temporarily relieves cough due to the common cold or inhaled irritants.
- Helps loosen mucus and bronchial secretions to make cough more productive.
Warnings
Warnings
Do not use if taking a prescription Monoamine Oxidase Inhibitor(MAOI) (certain drugs for Depression, psychiatric, or emotional condition or parkinson’s desease ), or for 2 weeks after stopping the MAOI Drug. If taking a prescription and do not know if it contains MAOI ask the Doctor before taking this product. Ask a Health Professional before use if: pregnant or breast feeding or suffer Diabetes. Stop use and ask a Doctor: if cough persists more than seven days or if accompanied by fever, rash, or persistant headache, these could be signs of a serious condition or illness.
Keep out of the reach of children, in case of accidental overdose seek professional assistance or contact a Poison Control Center immediately
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Shake well immediately before each use.
Do not exceed 6 doses in any 24 hour period.
| AGE | DOSES |
| Adults and Children 12 years and over | 10 ml (2 tsps) every 4 hours |
| Children 6 to under 12 years of age | 5 ml (1 tsp) every 4 hours |
| Children under 6 years of age | Do not use |
Indications & Usage
Other Information:Do not use if seal or cap is broken or torn, measure cup is provided
Store at 20 - 25 °C (68 - 77 °F).
Inactive Ingredient
Inactive Ingredients:Aloe Vera, Caramel color, Citric Acid, Eucalyptus, Ginger,Honey flavor, Hydroxyethyl cellulose Pharm 250, Menthol, Methylparaben,Potassium Sorbate,Propylene Glycol, Propylparaben, Purified water,Sodium Chloride, Sucralose.
Otc - Questions
Questions or Comments?
please call: 305-791-8763
Manufactured by
Gadal Laboratories, Inc., Miami, Fl 33186
Exclusively Distributed by
ROCKHEALTH, INC., Miami, Fl 33018
Made in U.S.A.
Package Label.Principal Display Panel
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