Indications and uses
Purpose Expectorant Uses helps loosen phlegm ( mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive
Giltuss EX Expectorant
- Manufacturer
- Dextrum Laboratories Inc.
- Effective date
- 2025-09-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:15:05
Label at a glance#
ProductGiltuss EX Expectorant
Active ingredientGUAIFENESIN
Label structure12 sections
Dosage and administration
Directions Do not take more than 6 doses in any 24 hours period Use enclosed dosing cup Keep dosing cup for use this product ml= mililiters Adults and children 12 years & over 10 ml every 4 hours children 6 to under 12 years of age 5 ml every 4 hours children 4 to under 6 years of age 2.5 ml every 4 hours children under 4 years of age Consult a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredients
Active Ingredients
Guafenesin, 400 mg
Uses
Purpose
Expectorant
Uses
- helps loosen phlegm ( mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive
Warnings
Warnings
- Ask a doctor before use if you have , cough that occurs with too much phlegm ( mucus) , persistent or chronic cough such occurs with smoking, asthma, or chronic bronchitis or emphysema
Stop Use
Stop use and ask a doctor if cough lasts for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache. A persistant cough may be a sign of a serious condition
If pregnant or breast -feeding
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 immediately
Directions
Directions
Do not take more than 6 doses in any 24 hours period
Use enclosed dosing cup
Keep dosing cup for use this product
ml= mililiters
Adults and children 12 years & over 10 ml every 4 hours
children 6 to under 12 years of age 5 ml every 4 hours
children 4 to under 6 years of age 2.5 ml every 4 hours
children under 4 years of age Consult a doctor
Other information
Other information
Store at room temperature 15-30 °C (59° -86 ° F)
Close cap tightly
SAVE CARTON FOR COMPLETE DRUG FACTS
Inactive Ingredients
Inactive Ingredients
Citric acid, glycerin, methylparaben,natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate,
Questions and comments
Questions and comments?
Call 1-787-848-9114, Monday-Friday 9AM-5PM EST
call your doctor for medical advice in the event of side effects
Indication and user section
Indication and usage
Do not take more than 6 doses in any 24- hours period.
Keep sosage cup for use with this product
Adults and children 12 years and over 10 ml every 4 hours
Children 6 to under 12 years of age 5ml every 4 hours
Children 4 to under 6 years of age 2.5ml ever 4 hours
Children under 4 years of age Consult a doctor
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 immediately
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Guafenesin 400 mg
Alcohol free, sugar free, Dye free, Non-Drowsy
Chest congestion, Phlegm & Mucus
Tutti Frutti Flavor
4 floz 118 ml
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
DailyMed Product Concepts#
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65852-008-04 | Giltuss EX Expectorant | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | 1 | |
| 65852-008-04 | Giltuss EX Expectorant | 1 in 1 CARTON | SOLUTION | 1 | 1 |
Products#
Every source-derived product name is available through these pages.
- Giltuss EX Expectorant
- Guaifenesin
- SUCRALOSE
- WATER
- CITRIC ACID
- SODIUM CITRATE
- PROPYLPARABEN
- GLYCERIN
- METHYLPARABEN
- PROPYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65852-008 | 65852-008-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| WATER | 059QF0KO0R | IACT |
| CITRIC ACID | 2968PHW8QP | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| Giltuss EX Expectorant | GUAIFENESIN | Dextrum Laboratories Inc. | 3f67ac3d-1503-3418-e063-6394a90a938f | 2025-09-22 | Warnings | 65852-008-04 65852-008 65852000804 3f67ac3d-1504-3418-e063-6394a90a938f 3f67ac3d-1503-3418-e063-6394a90a938f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.