The following Structured Product Label (SPL) was submitted to the FDA by Rockhealth, Inc for the product Libera Tos (NDC 60840-0200). 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, warnings, otc - keep out of reach of children, dosage & administration, indications & usage, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients:(in each teaspoonful 5 ml.) Purpose
Dextromethorphan Hydrobromide 10 mg .................................... Cough Suppressant
Guaifenesin 100 mg ................................................................... Expectorant
Uses:
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
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
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 |
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 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.
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.
Libera Tos Diabetic Label (Rh608400200)
* Please review the disclaimer below.
