Children's Giltuss Cough & Cold

Children's Giltuss Cough & Cold
SPL v1
SPL
SPL Set ID 3f025ef6-79e7-e833-e063-6294a90ab501
Route
ORAL
Published
Effective Date 2018-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (7.5 mg) Phenylephrine (5 mg) Guaifenesin (150 mg)
Inactive Ingredients
Methylparaben Propylene Glycol Water Sucralose Glycerin Propylparaben Sorbitol Solution Citric Acid Hydroxyethyl Cellulose, Unspecified Polyethylene Glycol, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-07

Description

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

Purpose

Purpose sectiion Cough Suppressant Expectorant Nasal descongestant


Medication Information

Purpose

Purpose sectiion Cough Suppressant Expectorant Nasal descongestant

Description

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

Section 53414-9

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

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.

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

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.

Principal Panel

Childrens 4-12

Cough & Cold

Alcohol free

Sugar free

Dye free

Non -Drowsy

Cherry Flavor

Purpose Sectiion

Purpose sectiion

Cough Suppressant

Expectorant

Nasal descongestant

Questions Section

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

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

Inactive Ingredients

Inactive Ingredients

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

Active Ingredients Section

Active ingredients ( in each 2.5 ml)

Dextrometorphan HBr, 7.5 mg

Guaifenesin,150 mg

Phenylephryne, 5 mg

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

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

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


Structured Label Content

Section 53414-9 (53414-9)

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

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.

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 (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

Ask A Doctor (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.

Principal Panel (Principal panel)

Childrens 4-12

Cough & Cold

Alcohol free

Sugar free

Dye free

Non -Drowsy

Cherry Flavor

Purpose Sectiion (Purpose sectiion)

Purpose sectiion

Cough Suppressant

Expectorant

Nasal descongestant

Questions Section (Questions section)

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

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

Inactive Ingredients

Inactive Ingredients

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

Active Ingredients Section (Active ingredients section)

Active ingredients ( in each 2.5 ml)

Dextrometorphan HBr, 7.5 mg

Guaifenesin,150 mg

Phenylephryne, 5 mg

Indication and Usage Section (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

Keep Out of Reach of Children (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

Directions and Other Information (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


Advanced Ingredient Data


Raw Label Data

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