GILTUSS CHILDRENS COUGH AND COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

Giltuss Childrens Cough and Cold by

Drug Labeling and Warnings

Giltuss Childrens Cough and Cold by is a Otc medication manufactured, distributed, or labeled by Dextrum Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients ( in each 2.5 ml) Purposes

Dextrometorphan HBr, 7.5 mg ----------------------Cough suppresant

Guafenesin, 150 mg -----------------------------------Expectorant

Phenylepryne HCL, 5 mg -----------------------------Nasal Decongestant

Use section

Uses * temporary relieves* cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants*

the intensity of coughing**the impulse to cough to help your child get to sleep* helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes*temporary relieves nasal congestion due to a cold*stuffy nose

Warnings

Donot use if your child is now taking a prescription monoamine oxidase inhibitor (MAOI) ( certain drugs for deppresion, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your's child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this oroduct.

Ask a doctor

Ask a doctor before use if your child has *heart desease, high blood pressure, thryroid desease, diabetes* a cough with too much phlegm ( mucus)* a persistent or chronic cough as occurs with asthma or chronic bronchitis

Ask a doctor or pharmacist before use if your child is taking any other nasal descongestant or stimulant, sedatives, tranquilizer, andndrugs used for depression, especially monoamine oxidase inhibitors (MAOIs)* When using this product do not use more than directed

Stop use and ask a Doctor if * nervousness,dizziness or sleeplesness occur* sympton do not get better within 7 days or are accompanied by fever* cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent haedache . These could be signs of serious conditions.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose , get medical or professional help or contact a Poisson Control Center inmediatly

Directions and other information

Directions* no take more than 6 doses in any 24 hours period * use enclosed dosing cup* keep dosage cup for use with this product* ml= mililiter

Children under 4 years ----Consult a doctor

children 4 to under 6 years------1.25 ml every 4 hours

children 6 to under 12 years-----2.5 ml every 4 hours

children 12 yeras and over -------5 ml every 4 hours

Other information

store at room temperature 15 - 30 0c* close cap tightly* save carton for complete drug facts

Questions section

Call 1-787-848-9114, Monday-Friday 9AM-5PM EST

Call your doctor for medical advice in the event of side efects

Active ingredients section

Active ingredients ( in each 2.5 ml)

Dextrometorphan HBr, 7.5 mg

Guaifenesin,150 mg

Phenylephryne, 5 mg

Inactive Ingredients

Inactive Ingredients

Citric Acid, Flavor, Glycerin, Hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose

Keep out of reach of children

Keep out of reach of children.

In case of accidental overdose , get medical or professional help or contact a Poison Control Center inmediatly

Indication and Usage section

Indication and Usage section

no take more than 6 doses in any 24 hours period

use enclosed dosing cup* keep dosage cup for use with this product* ml= mililiter

Children under 4 years ----Consult a doctor

children 4 to under 6 years------1.25 ml every 4 hours

children 6 to under 12 years-----2.5 ml every 4 hours

children 12 yeras and over -------5 ml every 4 hours

Purpose sectiion

Purpose sectiion

Cough Suppressant

Expectorant

Nasal descongestant

Principal panel

Childrens 4-12

Cough & Cold

Alcohol free

Sugar free

Dye free

Non -Drowsy

Cherry Flavor

INGREDIENTS AND APPEARANCE

GILTUSS CHILDRENS COUGH AND COLD 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65852-011
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	7.5 mg  in 2.5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 2.5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	150 mg  in 2.5 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
CITRIC ACID (UNII: 2968PHW8QP)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65852-011-04	1 in 1 CARTON	11/07/2018
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/07/2018

Labeler - Dextrum Laboratories Inc. (007392322)