DRKIDS CHILDRENS COUGH AND CHEST CONGESTION DM- dextromethorphan hydrobromide, guaifenesin solution

DrKids Childrens Cough and Chest Congestion DM by

Drug Labeling and Warnings

DrKids Childrens Cough and Chest Congestion DM by is a Otc medication manufactured, distributed, or labeled by CalmCo LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each 5mL)

Dextromethorphan HBr, USP, 5mg

Guaifenesin, USP, 100mg

Purpose

Cough suppressant

Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

Warnings

Do not use

if your child is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for two 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 giving this product.

Ask a doctor before use if your child has

persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if

cough lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

do not give more than 6 doses in any 24 hour period
give the recommended number of vials below, following the instructions under How to Open and Use on the side panel
empty all liquid in each Single-Use Vial when dosing

Dosing Chart

• Age (Years): Dose
• under 4 years: Consult a doctor
• 4 – 5 years: 1 Single-Use Vial (5 mL) every 4 hours
• 6 – 11 years: 1 – 2 Single-Use Vials (5 mL each) every 4 hours
• Adults and children 12 years and over: 2 – 4 Single-Use Vials (5 mL each) every 4 hours

Inactive Ingredients

citric acid, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Other information

• each Single-Use vial contains 6mg of sodium
• store at 20-25ºC (68-77ºF)
• tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken

Questions or comments?

941-202-3270 or visit www.DrKids.com

Package

INGREDIENTS AND APPEARANCE

DRKIDS CHILDRENS COUGH AND CHEST CONGESTION DM 
dextromethorphan hydrobromide, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73282-0013
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL (UNII: 506T60A25R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73282-0013-1	20 in 1 CARTON	12/15/2023
1		5 mL in 1 VIAL; 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	12/15/2023	10/31/2025

Labeler - CalmCo LLC (079308308)