FDA Label for Childrens Giltuss Ex Expectorant
View Indications, Usage & Precautions
Childrens Giltuss Ex Expectorant Product Label
The following document was submitted to the FDA by the labeler of this product Gil Pharmaceutical Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Tamper Evident: do not use if safety seal is broken or missing.
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
giltuss.com
Otc - Active Ingredient
Active ingredients (in each 5 mL)
Guaifenesin, 200 mg
Otc - Purpose
Purpose
Expectorant
Indications & Usage
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
Warnings
Otc - Ask Doctor
Ask a doctor before use if your child has
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma or chronic bronchitis
Otc - Stop Use
Stop use and ask a doctor if the child has a cough that lasts for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- do not take more than 6 doses in any 24-hour 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
Storage And Handling
Other information
- store at room temperature 15°-30°C (59°-86°F)
- close cap tightly
- SAVE CARTON FOR COMPLETE DRUG FACTS
Inactive Ingredient
Inactive ingredients citric acid, glycerin, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.
Otc - Questions
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.
Package Label.Principal Display Panel
Children 4-12
Children's Giltuss® EX EXPECTORANT
Alcohol Free, Sugar Free. Dye Free, Non Drowsy
CHEST CONGESTION
LIQUIFIES AND LOOSENS PHLEGM
LIQUIFIES AND REMOVES MUCUS
TUTTI FRUTTI FLAVOR
4FL OZ (118 mL)
* Please review the disclaimer below.