GILTUSS CHILDRENS ALLERGY PLUS- 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 Dextrum Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients ( in each 5 mL) Purpose

Chlorpheniramine maleate, USP 2 mg ------------------Antihistamine

Dextromethorphan HBr, USP 10 mg -----------------------Cough supressant

Phenylephrine HCl, USP 5 mg -------------------------------Nasal decongestant

indication and usage section

indication and usage section

Not take more than 6 doses in any 24-hour period

Use enclosed dosing cup

Keep dosage cup for use this product

ML=Milliliter

Children undre 6 years, consult the 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

Keep out of reach of children section

Keep out of reach of children section

In case of overdose, get medical help or contact a Poison Control Center right away.

Inactive ingredient section

Inactive ingredient section

Citric acid, flavor, glycerin, metylparaben, propylparaben, purified water, and sucralose.

Purpose section

Purpose section

Antihistamine

Cough Suppressant

Nasal Descongestant

Question section

Question section

Call 1-787-848-9114, Monday-Friday 9AM-5PM EST.

Call your doctor for medical advice in the event of side effects

Warnings Section

Warnings Section

Do not use to sedate a child or to makea child sleepy

in a child who is taking a prescription monoamine oxidase inhibitor(MAOI)(certain drugs for depression, psychiatric, or emotional condition, or Parkingson's disease), or for 2 weeks after stopping the MAOI drug.

If you do not know if your child's prescription drug contains a MAOI, ask a doctor or pharmacistbefore taking this products.

Dosage and administration section

Dosage and administration section

Not take more than 6 doses in any 24-hour period

Use enclosed dosing cup

Keep dosage cup for use this product

ML=Milliliter

Children undre 6 years, consult the 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

PRINCIPAL DISPLAY PANEL

Principal panel

Children 6-12

Children's Giltuss Allergy Plus

Cough & Congestion

Alcohol free, Sodium free, Sugar free,Dye free

Sneezing, runny nose, cough, itchy & watery eyes, sinus pressure, stuffy nose

Tutti Frutti flavor

4 floz ( 118 mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65852-018
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL
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

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color		Score
Shape		Size
Flavor	TUTTI FRUTTI	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65852-018-04	1 in 1 CARTON	11/07/2018
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/07/2018

Labeler - Dextrum Laboratories Inc. (007392322)