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
Active ingredients ( in each 5 ml) Purpose
Guaifenesin, 200 mg ----------------------------------------Expectorant
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
Store at room temperature 15-30 °C (59° -86 ° F)
Close cap tightly
SAVE CARTON FOR COMPLETE DRUG FACTS
Inactive Ingredients
Citric Acid, glycerin, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose
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 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
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
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65852-016-04 | Childrens Giltuss EX Expectorant | 1 in 1 CARTON | SOLUTION | 1 | 1 | |
| 65852-016-04 | Childrens Giltuss EX Expectorant | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65852-016 | 65852-016-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| WATER | 059QF0KO0R | IACT |
| CITRIC ACID | 2968PHW8QP | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Childrens Giltuss EX Expectorant | GUAIFENESIN | Dextrum Laboratories Inc. | 3f8d7d47-f14c-888c-e063-6394a90a5cdd | 2025-09-24 | Warnings | 65852-016-04 65852-016 65852001604 3f8d7d47-f14d-888c-e063-6394a90a5cdd 3f8d7d47-f14c-888c-e063-6394a90a5cdd |
Adverse event summaries are temporarily unavailable. Other product information remains available.