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Libera Tos by RockHealth, Inc

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: RockHealth, Inc
NDC Code: 60840-0200

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.

Libera Tos Diabetic

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

Dextromethorphan Hydrobromide 10 mg .................................... Cough Suppressant

Guaifenesin 100 mg ................................................................... Expectorant

Uses:

  • Temporarily relieves cough due to the common cold or inhaled irritants.
  • Helps loosen mucus and bronchial secretions to make cough more productive.

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 ºC (68 - 77 ºF).

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 
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60840-0200
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ALOE 
CARAMEL 
CITRIC ACID MONOHYDRATE 
EUCALYPTUS OIL 
GINGER 
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) 
MENTHOL 
METHYLPARABEN 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM CHLORIDE 
SUCRALOSE 
WATER 
Packaging
#Item CodePackage Description
1NDC:60840-0200-1118 mL in 1 BOTTLE
2NDC:60840-0200-2178 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/01/2013
Labeler - RockHealth, Inc (079130011)
Registrant - RockHealth, Inc (079130011)
Establishment
NameAddressID/FEIOperations
RockHealth, Inc079130011LABEL(60840-0200)
Establishment
NameAddressID/FEIOperations
Gadal Laboratories Inc841305639MANUFACTURE(60840-0200)

 
RockHealth, Inc

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Medically reviewed on Nov 1, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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