FDA Label for Giltuss Childrens Allergy Plus Cough And Congestion
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Giltuss Childrens Allergy Plus Cough And Congestion 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)
Chlorpheniramine maleate USP, 2 mg
Dextromethorphan HBr USP, 10 mg
Phenylephrine HCl USP, 5 mg
Otc - Purpose
Purposes
Antihistamine
Cough Suppressant
Nasal decongestant
Indications & Usage
Uses
- temporarily relieves
- cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
- nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporarily restores freer breathing through the nose
Warnings
Warnings
Otc - Do Not Use
Do not use
- to sedate a child or to make a child sleepy
- in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Otc - Ask Doctor
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or persistent or chronic cough that lasts such as occurs with asthma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is
- taking sedatives or tranquilizers
- taking any other oral nasal decongestant or stimulant
Otc - When Using
When using this product
- do not use more than directed
- may cause marked drowsiness
- excitability may occur, especially in children
Otc - Stop Use
Stop use and ask a doctor if
- nervousness, dizzyness, or sleepless occurs
- symptoms do not get better within 7 days or are accompanied by a fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding,ask a health professional before use.
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
- not take more than 6 doses in any 24-hour period
- use enclosed dosing cup
- keep dosage cup for use with this product
- mL=milliter
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 |
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, flavor, glycerin, methylparaben, propylparaben, purified water and 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's
Giltuss® ALLERGY PLUS COUGH & CONGESTION
ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT
Alcohol Free. Sodium Free. Sugar Free. Dye Free.
- SNEEZING
- RUNNY NOSE
- COUGH
- ITCHY & WATERY EYES
- STUFFY NOSE
- SINUS PRESSURE
TUTTI FRUTTI FLAVOR
4 FL OZ (118 mL)
* Please review the disclaimer below.