Children's Giltuss Ex Expectorant

SPL v1

SPL

SPL Set ID 3f8d7d47-f14c-888c-e063-6394a90a5cdd

Route

ORAL

Published

Effective Date 2020-06-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (200 mg)

Inactive Ingredients

Methylparaben Polyethylene Glycol, Unspecified Glycerin Propylparaben Sucralose Water Citric Acid Sodium Citrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-06-22

Description

Active ingredients ( in each 5 ml) Purpose Guaifenesin, 200 mg ----------------------------------------Expectorant

Medication Information

Description

Active ingredients ( in each 5 ml) Purpose Guaifenesin, 200 mg ----------------------------------------Expectorant

Uses

Section 51945-4

Children 4 -12

Children's Giltuss EX

Expectorant

Guaifenesin, 200 mg

Alcohol free, Sugar free, Dye free, Non-Drowsy

Chest congestion liquifies and loosen phlegm and mucus

Tutti Frutti flavor

4 floz 118 ml

Warnings

Directions

Directions

Do not take more than 6 doses in any 24 hours period

use enclosed dosing cup

Keep dosage cup for use with this product

ml= mililiters

children under 4 years of age Consult a doctor

children 4 to under 6 years of age 2.5 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

Adults and children 12 years & over 10 ml every 4 hours

Stop Use Section

Other Information

Other information

Store at room temperature 15-30 °C (59° -86 ° F)

Close cap tightly

SAVE CARTON FOR COMPLETE DRUG FACTS

Active Ingredients

Active ingredients ( in each 5 ml) Purpose

Guaifenesin, 200 mg ----------------------------------------Expectorant

Inactive Ingredients

Inactive Ingredients

Citric Acid, glycerin, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions Or Comments

Questions or comments?

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

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

Indication for Use Section

indication an user section

Do not take more than 6 doses in any 24 hours period

use enclosed dosing cup

Keep dosage cup for use with this product

ml= mililiters

children under 4 years of age Consult a doctor

children 4 to under 6 years of age 2.5 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

Adults and children 12 years & over 10 ml every 4 hours

Keep Out of Reach of Children

Structured Label Content

Uses

Section 51945-4 (51945-4)

Children 4 -12

Children's Giltuss EX

Expectorant

Guaifenesin, 200 mg

Alcohol free, Sugar free, Dye free, Non-Drowsy

Chest congestion liquifies and loosen phlegm and mucus

Tutti Frutti flavor

4 floz 118 ml

Warnings

Directions

Directions

Do not take more than 6 doses in any 24 hours period

use enclosed dosing cup

Keep dosage cup for use with this product

ml= mililiters

children under 4 years of age Consult a doctor

children 4 to under 6 years of age 2.5 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

Adults and children 12 years & over 10 ml every 4 hours

Stop Use Section (Stop use section)

Other Information

Other information

Store at room temperature 15-30 °C (59° -86 ° F)

Close cap tightly

SAVE CARTON FOR COMPLETE DRUG FACTS

Active Ingredients

Active ingredients ( in each 5 ml) Purpose

Guaifenesin, 200 mg ----------------------------------------Expectorant

Inactive Ingredients

Inactive Ingredients

Citric Acid, glycerin, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions Or Comments (Questions or comments)

Questions or comments?

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

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

Indication for Use Section (indication for use section)

indication an user section

Do not take more than 6 doses in any 24 hours period

use enclosed dosing cup

Keep dosage cup for use with this product

ml= mililiters

children under 4 years of age Consult a doctor

children 4 to under 6 years of age 2.5 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

Adults and children 12 years & over 10 ml every 4 hours

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"51945-4": "Children 4 -12 Children's Giltuss EX Expectorant Guaifenesin, 200 mg Alcohol free, Sugar free, Dye free, Non-Drowsy Chest congestion liquifies and loosen phlegm and mucus Tutti Frutti flavor 4 floz 118 ml", "Directions": "Directions Do not take more than 6 doses in any 24 hours period use enclosed dosing cup Keep dosage cup for use with this product ml= mililiters children under 4 years of age Consult a doctor children 4 to under 6 years of age 2.5 ml every 4 hours children 6 to under 12 years of age 5 ml every 4 hours Adults and children 12 years & over 10 ml every 4 hours", "Other Information": "Other information Store at room temperature 15-30 °C (59° -86 ° F) Close cap tightly SAVE CARTON FOR COMPLETE DRUG FACTS", "Active Ingredients": "Active ingredients ( in each 5 ml) Purpose Guaifenesin, 200 mg ----------------------------------------Expectorant", "Inactive Ingredients": "Inactive Ingredients Citric Acid, glycerin, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose", "Questions or comments": "Questions or comments? Call 1-787-848-9114, Monday-Friday 9AM – 5PM EST Call your doctor for medical advice in the event of side effects.", "indication for use section": "indication an user section Do not take more than 6 doses in any 24 hours period use enclosed dosing cup Keep dosage cup for use with this product ml= mililiters children under 4 years of age Consult a doctor children 4 to under 6 years of age 2.5 ml every 4 hours children 6 to under 12 years of age 5 ml every 4 hours Adults and children 12 years & over 10 ml every 4 hours"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:09.255609 · Updated: 2026-03-14T23:10:23.192014