DrKids Children's Multi-Symptom Cold, Cough and Congestion DM

DrKids Childrens Multi Symptom Cold Cough and Congestion DM by

Drug Labeling and Warnings

DrKids Childrens Multi Symptom Cold Cough and Congestion DM by is a Otc medication manufactured, distributed, or labeled by Calmco. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRKIDS CHILDRENS MULTI SYMPTOM COLD COUGH AND CONGESTION DM- dextromethorphn hbr 5mg, guaifenesin 100mg, phenylephrine hcl 2.5mg solution 
Calmco

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DrKids Children's Multi-Symptom Cold, Cough and Congestion DM

Active Ingredients (in each 5 mL)

Dextromethorphan HBr, 5mg

Guaifenesin, 100mg

Phenylephrine HCl, 2.5mg

Purposes

Cough suppressant

Expectorant

Nasal Decongestant

Uses

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help your child get to sleep ■ nasal congestion due to a cold ■ stuffy nose

Warnings

Do not use

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 giving this product.

Ask a doctor if your child has

■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ cough that occurs with too much phlegm (mucus) ■ persistent or chronic cough such as occurs with asthma

Ask a doctor or pharmacist before use if your child is

taking any other decongestant or stimulant.

When using this product

do not exceed recommended dosage (see overdose warning)

Stop use and ask a doctor if

■ nervousness, dizziness, or sleeplessness occur ■ symptoms do not get better within 7 days or occur with fever ■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs 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

■ this product does not contain directions or complete warnings for adult use

■ do not give more than 6 times in 24 hours

■ give the recommended number of vials below following the instructions under “Easy to Use” on the side panel.

■ empty all liquid in each Single-Use Vial when dosing

■ use the chart below to confirm the dose

Dosing chart

• Age (years): Dose (mL)
• under 4 years: Do not use
• 4 to 5 years: 1 Single-Use Vial (5mL) every 4 hours. Do not give more than 6 times in 24 hours
• 6 to 11 years: 2 Single-Use Vials (10mL) every 4 hours. Do not give more than 6 times in 24 hours

Other information

■ each Single -Use vial contains 5mg of sodium

■ store at 20-25°C (68-77°F)

■ tamper-evident: do not use if the top flap of the box is open. Do not use if any vial is open or broken.

Inactive ingredients

citric acid, edetate disodium, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate, xanthan gum.

Questions or Comments?

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

Package Label

DRKIDS CHILDRENS MULTI SYMPTOM COLD COUGH AND CONGESTION DM 
dextromethorphn hbr 5mg, guaifenesin 100mg, phenylephrine hcl 2.5mg solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73282-0116
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL
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
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73282-0116-1	20 in 1 CARTON	02/15/2024
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	02/15/2024	02/15/2024

Labeler - Calmco (079308308)

Revised: 5/2024

Document Id: 1934d927-975b-7ab1-e063-6294a90a3775

34390-5

Set id: d4ebf09c-c364-2529-e053-2995a90ae53f

Version: 4

Effective Time: 20240524