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
The following Structured Product Label (SPL) was submitted to the FDA by Gil Pharmaceutical Corp for the product Giltuss Childrens Allergy Plus (NDC 58552-139). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
Active ingredients (in each 5 mL)
Chlorpheniramine maleate USP, 2 mg
Dextromethorphan HBr USP, 10 mg
Phenylephrine HCl USP, 5 mg
Purposes
Antihistamine
Cough Suppressant
Nasal decongestant
Uses
Warnings
Do not use
Ask a doctor before use if the child has
Ask a doctor or pharmacist before use if the child is
When using this product
Stop use and ask a doctor if
These could be signs of a serious condition.
If pregnant or breastfeeding,ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
| children under 6 years | Consult a Doctor |
| children 6 to under 12 years | 5 mL every 4 to 6 hours |
| adults and children 12 years and over | 10 mL every 4 to 6 hours |
Other information
Inactive ingredients
citric acid, flavor, glycerin, methylparaben, propylparaben, purified water and 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.
Children's
Giltuss® ALLERGY PLUS COUGH & CONGESTION
ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT
Alcohol Free. Sodium Free. Sugar Free. Dye Free.
TUTTI FRUTTI FLAVOR
4 FL OZ (118 mL)
* Please review the disclaimer below.