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Sancochito Compuesto

Medically reviewed on December 23, 2017

Dosage form: syrup
Ingredients: GUAIFENESIN 100mg in 5mL
Labeler: Laboratorios Dr. Collado, S.A.
NDC Code: 42333-120

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.

Sancochito Compuesto

Active Ingredient:

Each 5 mL contains:

Guaifenesin....100mg

Purpose

Expectorant

Other Ingredients:

Distilled Water, Glucose and Fructose Syrup, Methyl Paraben, Propyl Paraben, Propylene Glycol, Ricino Oil, Sodium Benzoate, Sodium Chloride, Sucralose, Sucralose, Xanthan Gum

Directions:

SHAKE BEFORE USING

  • Adults and children 12 years of age and over:  Oral dosage is 200 to 400 milligrams every 4 hours not to exceed 2,400 milligrams in 24 hours.
  • Children 6 to under 12 years of age:  Oral dosage is 100 to 200 milligrams every 4 hours not to exceed 1,200 milligrams in 24 hours.
  • Children 2 to under 6 years of age: Oral dosage is 500 to 100 milligrams every 4 hours not to exceed 600 milligrams in 24 hours.  Children under 2 years of age: consult a doctor.

Use:

Helps loosen Phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings:

  • Keep this product out of reach of children.  A persistent cough may be the sign of a serious condition.  If cough persists for more than 1 week or accompanied by fever, reach or persistent headache consult a doctor immediately.

If pregnant or breast-feeding, ask a health professional before use.  In case of overdose, contact a health professional or Poison Control Center right away.

Package Labeling:

SANCOCHITO COMPUESTO 
guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42333-120
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
METHYLPARABEN 
PROPYLPARABEN 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SUCRALOSE 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:42333-120-0460 mL in 1 BOTTLE
2NDC:42333-120-02120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/23/2017
Labeler - Laboratorios Dr. Collado, S.A. (817468001)

 
Laboratorios Dr. Collado, S.A.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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