Label: LIBERA TOS- dextromethorphan hbr, guaifenesin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 60840-0200-1, 60840-0200-2 - Packager: RockHealth, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 1, 2013
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- ACTIVE INGREDIENT
- PURPOSE
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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
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIBERA TOS
dextromethorphan hbr, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60840-0200 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) CARAMEL (UNII: T9D99G2B1R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EUCALYPTUS OIL (UNII: 2R04ONI662) GINGER (UNII: C5529G5JPQ) HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CHLORIDE (UNII: 451W47IQ8X) SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60840-0200-1 118 mL in 1 BOTTLE 2 NDC:60840-0200-2 178 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/01/2013 Labeler - RockHealth, Inc (079130011) Registrant - RockHealth, Inc (079130011) Establishment Name Address ID/FEI Business Operations RockHealth, Inc 079130011 LABEL(60840-0200) Establishment Name Address ID/FEI Business Operations Gadal Laboratories Inc 841305639 MANUFACTURE(60840-0200)