SPL v1
SPL
SPL Set ID 40802fb6-c1ec-d7b0-e063-6394a90ab423
Route
ORAL
Published
Effective Date 2018-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Methylparaben Citric Acid Propylparaben Sucralose Water Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-02

Description

Indication and usage section Not take more than 6 doses in any 24 hours period. Use enclosed dosing cup. keep dosage cup for use with this product ML=Milliliters Children under 4 years, consult a doctor Children 4 to under 6 years, 2.5 ml every 4 hours Children 6 to under 12 years, 5 ml every 4 hours Children 12 years and over, 10 ml every 4 hours

Purpose

Purpose section Cough suppressant Expectorant


Medication Information

Purpose

Purpose section Cough suppressant Expectorant

Description

Indication and usage section Not take more than 6 doses in any 24 hours period. Use enclosed dosing cup. keep dosage cup for use with this product ML=Milliliters Children under 4 years, consult a doctor Children 4 to under 6 years, 2.5 ml every 4 hours Children 6 to under 12 years, 5 ml every 4 hours Children 12 years and over, 10 ml every 4 hours

Warnings

Warnings

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

Purpose Section

Purpose section

Cough suppressant

Expectorant

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.

Stop Use Section

stop use section

Stop use ans ask doctor of pharmacist if the child has symptoms do not get better within 7 days or are accompanied by fever, cough comes back or is accompanied by fever rash or persistent headache.

Ask A Doctor Section

Ask a doctor section

Ask a doctor before use if the child has

cough that occurs with much phlegm(mucus)

a breathing problem or persistent or chronic cough that lasts such as occurs with asthma.

Active Ingredient Section

Active ingredient section

(in each 5 ml)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Indication and Usage Section

Indication and usage section

Not take more than 6 doses in any 24 hours period.

Use enclosed dosing cup. keep dosage cup for use with this product

ML=Milliliters

Children under 4 years, consult a doctor

Children 4 to under 6 years, 2.5 ml every 4 hours

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

Children 12 years and over, 10 ml every 4 hours

Dosage and Administratiion Section

Dosage and Administratiion section

Not take more than 6 doses in any 24 hours period.

Use enclosed dosing cup. keep dosage cup for use with this product

ML=Milliliters

Children under 4 years, consult a doctor

Children 4 to under 6 years, 2.5 ml every 4 hours

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

Children 12 years and over, 10 ml every 4 hours

Keep Out of Reach of Childrens Section

Keep out of reach of childrens section

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

Package Label. Principal Display Panel

Package Label. Principal Display Panel

G Children, ninos 4-12

Children's

Giltuss

Cough & Chest Congestion

Tos y Congestion de Pecho

Alcohol Free. Sugar Free. Dye Free. Non-Drowsy

Sin Alcohol. Sin Azucar. Sin Colorantes. No causa sueno.

COUGH & COLD, CHEST CONGESTION, LIQUIFIES

AND LOOSSEN PHLEGM AND MUCUS

TOS Y CATARRO, CONGESTION DE PECHO,

LIQUA Y SUELTA LA FLEMA Y EL MOCO

RASBERRY FLAVOIR.

SABOR A FRAMBUESA. 4 FL OZ (118 ml)


Structured Label Content

Warnings

Warnings

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

Purpose Section (Purpose section)

Purpose section

Cough suppressant

Expectorant

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.

Stop Use Section (stop use section)

stop use section

Stop use ans ask doctor of pharmacist if the child has symptoms do not get better within 7 days or are accompanied by fever, cough comes back or is accompanied by fever rash or persistent headache.

Ask A Doctor Section (Ask a doctor section)

Ask a doctor section

Ask a doctor before use if the child has

cough that occurs with much phlegm(mucus)

a breathing problem or persistent or chronic cough that lasts such as occurs with asthma.

Active Ingredient Section (Active ingredient section)

Active ingredient section

(in each 5 ml)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Indication and Usage Section (Indication and usage section)

Indication and usage section

Not take more than 6 doses in any 24 hours period.

Use enclosed dosing cup. keep dosage cup for use with this product

ML=Milliliters

Children under 4 years, consult a doctor

Children 4 to under 6 years, 2.5 ml every 4 hours

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

Children 12 years and over, 10 ml every 4 hours

Dosage and Administratiion Section (Dosage and Administratiion section)

Dosage and Administratiion section

Not take more than 6 doses in any 24 hours period.

Use enclosed dosing cup. keep dosage cup for use with this product

ML=Milliliters

Children under 4 years, consult a doctor

Children 4 to under 6 years, 2.5 ml every 4 hours

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

Children 12 years and over, 10 ml every 4 hours

Keep Out of Reach of Childrens Section (Keep out of reach of childrens section)

Keep out of reach of childrens section

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

Package Label. Principal Display Panel

Package Label. Principal Display Panel

G Children, ninos 4-12

Children's

Giltuss

Cough & Chest Congestion

Tos y Congestion de Pecho

Alcohol Free. Sugar Free. Dye Free. Non-Drowsy

Sin Alcohol. Sin Azucar. Sin Colorantes. No causa sueno.

COUGH & COLD, CHEST CONGESTION, LIQUIFIES

AND LOOSSEN PHLEGM AND MUCUS

TOS Y CATARRO, CONGESTION DE PECHO,

LIQUA Y SUELTA LA FLEMA Y EL MOCO

RASBERRY FLAVOIR.

SABOR A FRAMBUESA. 4 FL OZ (118 ml)


Advanced Ingredient Data


Raw Label Data

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