GILTUSS CHILDRENS ALLERGY PLUS COUGH AND CONGESTION- chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution

Giltuss Childrens Allergy Plus by

Drug Labeling and Warnings

Giltuss Childrens Allergy Plus by is a Otc medication manufactured, distributed, or labeled by Gil Pharmaceutical Corp, Dextrum Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 mL)

Chlorpheniramine maleate USP, 2 mg

Dextromethorphan HBr USP, 10 mg

Phenylephrine HCl USP, 5 mg

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

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.

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

Ask a doctor or pharmacist before use if the child is

• taking sedatives or tranquilizers
• taking any other oral nasal decongestant or stimulant

When using this product

• do not use more than directed
• may cause marked drowsiness
• excitability may occur, especially in children

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.

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.

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

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.

SPL UNCLASSIFIED SECTION

Tamper evident: do not use if safety seal is broken or missing

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

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)

INGREDIENTS AND APPEARANCE

GILTUSS CHILDRENS ALLERGY PLUS  COUGH AND CONGESTION
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-139
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	yellow (Light yellow)	Score
Shape		Size
Flavor	TUTTI FRUTTI	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-139-04	1 in 1 CARTON	11/07/2018
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/07/2018

Labeler - Gil Pharmaceutical Corp (176826592)

Establishment
Name	Address	ID/FEI	Business Operations
Dextrum Laboratories Inc.		007392322	manufacture(58552-139)