LIBERA TOS- dextromethorphan hbr, guaifenesin liquid

Libera Tos by

Drug Labeling and Warnings

Libera Tos by is a Otc medication manufactured, distributed, or labeled by RockHealth, Inc, Gadal Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:(in each teaspoonful 5 ml.)                                Purpose

Dextromethorphan Hydrobromide 5 mg .................................. Cough Suppressant

Guaifenesin 75 mg ................................................................... Expectorant

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

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
• 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 ºC (68 - 77 ºF).

INACTIVE INGREDIENT

Inactive Ingredients:Aloe Vera, Caramel Color, Citric Acid, Eucalyptus, Pure Honey, Ginger,Honey flavor, Hydroxyethyl cellulose Pharm 250, Menthol, Methylparaben,Potassium Sorbate,Propylene Glycol, Propylparaben, Purified water,Sodium Chloride, Sucralose.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIBERA TOS 
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60840-0300
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	75 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
CARAMEL (UNII: T9D99G2B1R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EUCALYPTUS OIL (UNII: 2R04ONI662)
HONEY (UNII: Y9H1V576FH)
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: 60840-0300-1	118 mL in 1 BOTTLE
2	NDC: 60840-0300-2	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(60840-0300)

Establishment
Name	Address	ID/FEI	Business Operations
Gadal Laboratories Inc		841305639	MANUFACTURE(60840-0300)