CHILDRENS GILTUSS HONEY DM COUGH- dextromethorphan hbr liquid

Childrens Giltuss Honey DM Cough by

Drug Labeling and Warnings

Childrens Giltuss Honey DM Cough by is a Otc medication manufactured, distributed, or labeled by Dextrum Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Do not take more than 4 doses in any 24 hours period Keep sosage cup for use with this product

children under 4 years, consult a doctor

children 6 to under 12 years, 5ml every 6-8 hours

children 12 years and over, 10ml every 6-8 hours

ACTIVE INGREDIENT

Active ingredient (in each 5ml)

Active Ingredients ( in each 5 mL)

Dextromethorphan15mg

purpose cough suppresant

WARNINGS

Do not use if your child is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fotdepression, psychriatic or emotional condition, orParkinso's desese), or for 2 weeksafter stoppings the MAOI drugs. If you do not know if your child prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

STOP USE

Stop use and ask a doctorif the child has a cough that last more than 7 days, comes back or is accompanied byfever, rash or persistent headache. These could be signs of a serius condition.

PURPOSE

Purpose section Cough Suppresant

ASK DOCTOR

Ask a doctor before use if the child has couhg that occurs with too muchmucus

a persistent or chronic cough such as occurs with sthma.

OTHER SAFETY INFORMATION

Temporarily relieves: cough due to minor thoroat and brochial irritation associated with the common cold or inhaled irritants

the intensity of coughing

The impulse to cough to help your child get to sleep

QUESTIONS

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

Call your doctor for medeical advice in the event of side effects.

Dosage and administration

Dosage and administration

Do not take more than 4 doses in any 24 hours period Keep sosage cup for use with this product

children under 4 years, consult a doctor

children 6 to under 12 years, 5ml every 6-8 hours

children 12 years and over, 10ml every 6-8 hours

Inactive ingredient

Inactive ingredients:

Natural and artificial flavor, natural grade A Honey, Methylparaben, potassium Sorbate, propylene Glycol, propylparaben, purified water, sucralose

Principal display panel

Children giltuss honey DM 4-12

Alcohol Free

DYE free

Non Drowsy

Certified Honey

Honey Lemon Flavor

INGREDIENTS AND APPEARANCE

CHILDRENS GILTUSS HONEY DM COUGH 
dextromethorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65852-007
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HONEY (UNII: Y9H1V576FH)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	HONEY, LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65852-007-04	1 in 1 CARTON	06/22/2020
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	06/22/2020

Labeler - Dextrum Laboratories Inc (007392322)