CHILDRENS GILTUSS HONEY COUGH AND CHEST CONGESTION- dextromethorphan hbr, guaifenesin solution

Childrens Giltuss Honey Cough and Chest Congestion by

Drug Labeling and Warnings

Childrens Giltuss Honey Cough and Chest Congestion 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) Purposes

Dextromethorphan HBr, 10 mg ------------------------Cough Suppresant

Guaifenesin, 100 mg --------------------------------------Expectorant

Uses

Uses

Uses

Temporary relieves:

Cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants, the intensity of coughing , the impulse to cough to help your child get to sleep, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive

warnings

Warnings

Do not use

If your child is now 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 don’t know is your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if the child has

Warnings

Ask a doctor before use if your child has, cough that occurs with too much phlegm (mucus) , a persistent or chronic cough as occurs with asthma.

Stop use

Stop use and ask a doctor if

cough lasts for more than 7 days , come back, or is accompanied by fever, rash or persistent headache. These could be signs of serious condition.

Keep out of reach of children

Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately

Directions

Directions

Do not take more than 6 doses in any 24 hours period

use enclosed dosing cup

Keep dosage cup for use with this product

ml= milliliters

children under 4 years of age Consult a doctor

children 4 to under 6 years of age 2.5 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

Adults and children 12 years & over 10 ml every 4 hours

Other information

Other information

Store at room temperature 15-30 °C (59° -86 ° F)
Close cap tightly
SAVE CARTON FOR COMPLETE DRUG FACTS

Inactive ingredients

Inactive ingredients

Carboxymethylcellulose sodium, citric acid, glycerin, natural and artificial flavor, natural grade A honey, methylparaben, propylene glycol, propylparaben, purified water,sucralose

Questions or comments?

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.

Indication and usage section

Indication and usage section

Do not take more than 6 doses in any 24 hours period

use enclosed dosing cup

Keep dosage cup for use with this product

ml= milliliters

children under 4 years of age Consult a doctor

children 4 to under 6 years of age 2.5 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

Adults and children 12 years & over 10 ml every 4 hours

PRINCIPAL DISPLAY PANEL

Children 4-12

Alcohol free, Dye free, Non-drowsy

True source certified honey

Children's Giltuss Honey

Cough & Chest Congestion

Cough & cold, chest congestion, liquifies and loosen phlegm and mucus

Honey lemon flavor

4 floz 118 ml

INGREDIENTS AND APPEARANCE

CHILDRENS GILTUSS HONEY COUGH AND CHEST CONGESTION 
dextromethorphan hbr, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65852-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
HONEY (UNII: Y9H1V576FH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)

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: 65852-003-04	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)