Sancochito Compuesto (Guaifenesin) Syrup [Laboratorios Dr. Collado, S.a.] -

SANCOCHITO COMPUESTO (GUAIFENESIN) SYRUP [LABORATORIOS DR. COLLADO, S.A.]
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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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	05/23/2017

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

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Medic