Children's Giltuss Allergy Plus

Children's Giltuss Allergy Plus
SPL v1
SPL
SPL Set ID 3fa5220f-38bb-9ef6-e063-6294a90aeff8
Route
ORAL
Published
Effective Date 2018-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Chlorpheniramine (2 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Citric Acid Methylparaben Propylparaben Water Sucralose Glycerin

Identifiers & Packaging

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

Description

Active Ingredients ( in each 5 mL) Purpose Chlorpheniramine maleate, USP 2 mg ------------------Antihistamine Dextromethorphan HBr, USP 10 mg -----------------------Cough supressant Phenylephrine HCl, USP 5 mg -------------------------------Nasal decongestant

Purpose

Purpose section Antihistamine Cough Suppressant Nasal Descongestant

Dosage and Administration

Dosage and administration section Not take more than 6 doses in any 24-hour period Use enclosed dosing cup Keep dosage cup for use this product ML=Milliliter Children undre 6 years, consult the doctor Children 6 to under 12 years, 5 ml every 4 to 6 hours Adults and children 12 years and over, 10 ml every 4 to 6 hours


Medication Information

Purpose

Purpose section Antihistamine Cough Suppressant Nasal Descongestant

Dosage and Administration

Dosage and administration section Not take more than 6 doses in any 24-hour period Use enclosed dosing cup Keep dosage cup for use this product ML=Milliliter Children undre 6 years, consult the doctor Children 6 to under 12 years, 5 ml every 4 to 6 hours Adults and children 12 years and over, 10 ml every 4 to 6 hours

Description

Active Ingredients ( in each 5 mL) Purpose Chlorpheniramine maleate, USP 2 mg ------------------Antihistamine Dextromethorphan HBr, USP 10 mg -----------------------Cough supressant Phenylephrine HCl, USP 5 mg -------------------------------Nasal decongestant

Section 51945-4

Principal panel

Children 6-12

Children's Giltuss Allergy Plus

Cough & Congestion

Alcohol free, Sodium free, Sugar free,Dye free

Sneezing, runny nose, cough, itchy & watery eyes, sinus pressure, stuffy nose

Tutti Frutti flavor

4 floz ( 118 mL)

Purpose Section

Purpose section

Antihistamine

Cough Suppressant

Nasal Descongestant

Question Section

Question section

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

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

Warnings Section

Warnings Section

Do not use to sedate a child or to makea child sleepy

in a child who is taking a prescription monoamine oxidase inhibitor(MAOI)(certain drugs for depression, psychiatric, or emotional condition, or Parkingson's disease), or for 2 weeks after stopping the MAOI drug.

If you do not know if your child's prescription drug contains a MAOI, ask a doctor or pharmacistbefore taking this products.

Active Ingredients

Active Ingredients ( in each 5 mL) Purpose

Chlorpheniramine maleate, USP 2 mg ------------------Antihistamine

Dextromethorphan HBr, USP 10 mg -----------------------Cough supressant

Phenylephrine HCl, USP 5 mg -------------------------------Nasal decongestant

Inactive Ingredient Section

Inactive ingredient section

Citric acid, flavor, glycerin, metylparaben, propylparaben, purified water, and sucralose.

Indication and Usage Section

indication and usage section

Not take more than 6 doses in any 24-hour period

Use enclosed dosing cup

Keep dosage cup for use this product

ML=Milliliter

Children undre 6 years, consult the doctor

Children 6 to under 12 years, 5 ml every 4 to 6 hours

Adults and children 12 years and over, 10 ml every 4 to 6 hours

Dosage and Administration Section

Dosage and administration section

Not take more than 6 doses in any 24-hour period

Use enclosed dosing cup

Keep dosage cup for use this product

ML=Milliliter

Children undre 6 years, consult the doctor

Children 6 to under 12 years, 5 ml every 4 to 6 hours

Adults and children 12 years and over, 10 ml every 4 to 6 hours

Keep Out of Reach of Children Section

Keep out of reach of children section

In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Section 51945-4 (51945-4)

Principal panel

Children 6-12

Children's Giltuss Allergy Plus

Cough & Congestion

Alcohol free, Sodium free, Sugar free,Dye free

Sneezing, runny nose, cough, itchy & watery eyes, sinus pressure, stuffy nose

Tutti Frutti flavor

4 floz ( 118 mL)

Purpose Section (Purpose section)

Purpose section

Antihistamine

Cough Suppressant

Nasal Descongestant

Question Section (Question section)

Question section

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

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

Warnings Section

Warnings Section

Do not use to sedate a child or to makea child sleepy

in a child who is taking a prescription monoamine oxidase inhibitor(MAOI)(certain drugs for depression, psychiatric, or emotional condition, or Parkingson's disease), or for 2 weeks after stopping the MAOI drug.

If you do not know if your child's prescription drug contains a MAOI, ask a doctor or pharmacistbefore taking this products.

Active Ingredients

Active Ingredients ( in each 5 mL) Purpose

Chlorpheniramine maleate, USP 2 mg ------------------Antihistamine

Dextromethorphan HBr, USP 10 mg -----------------------Cough supressant

Phenylephrine HCl, USP 5 mg -------------------------------Nasal decongestant

Inactive Ingredient Section (Inactive ingredient section)

Inactive ingredient section

Citric acid, flavor, glycerin, metylparaben, propylparaben, purified water, and sucralose.

Indication and Usage Section (indication and usage section)

indication and usage section

Not take more than 6 doses in any 24-hour period

Use enclosed dosing cup

Keep dosage cup for use this product

ML=Milliliter

Children undre 6 years, consult the doctor

Children 6 to under 12 years, 5 ml every 4 to 6 hours

Adults and children 12 years and over, 10 ml every 4 to 6 hours

Dosage and Administration Section (Dosage and administration section)

Dosage and administration section

Not take more than 6 doses in any 24-hour period

Use enclosed dosing cup

Keep dosage cup for use this product

ML=Milliliter

Children undre 6 years, consult the doctor

Children 6 to under 12 years, 5 ml every 4 to 6 hours

Adults and children 12 years and over, 10 ml every 4 to 6 hours

Keep Out of Reach of Children Section (Keep out of reach of children section)

Keep out of reach of children section

In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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