SANCOCHITO COMPUESTO- guaifenesin syrup

Sancochito Compuesto by

Drug Labeling and Warnings

Sancochito Compuesto by is a Otc medication manufactured, distributed, or labeled by Laboratorios Dr. Collado, S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

SANCOCHITO COMPUESTO 
guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42333-120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42333-120-04	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2017
2	NDC: 42333-120-02	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/23/2017

Labeler - Laboratorios Dr. Collado, S.A. (817468001)