DR KIDS COUGH AND CHEST CONGESTION- dextromethorphan hbr, guaifenesin solution

Dr Kids by

Drug Labeling and Warnings

Dr Kids by is a Otc medication manufactured, distributed, or labeled by CalmCo LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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Active Ingredient and Purpose

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• Active ingredient (in each 5 mL vial): Purpose
• Dextromethorphan HBr 5mg..............: Cough supressant
• Guaifenesin 100mg............: Expectorant

Uses

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

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 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

• a persistent or chronic cough such as occurs with asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if your child has

• a cough that persists for more than 1 week, 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 accidental 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 exceed 6 doses in a 24-hour period
• follow the “Easy to Use” instructions on the pouch
• use the dose that corresponds to your child’s age
• discard unused portion

• Age (Years): Dose
• Under 4: consult a doctor
• 4 to under 6: 1 vial every 4 hours
• 6 to under 12: 1-2 vials every 4 hours
• 12 and older: 2-4 vials every 4 hours

Other information

• each 5 mL vial contains: sodium 7 mg
• store between 68-77°F (20-25°C)
• do not use if pouch or vial is punctured, torn or open

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose, flavor, propylene glycol, sodium benzoate, saccharin sodium, sorbitol, sucralose, water

Questions or comments?

+1-941-202-3270 (M-F) 9AM-5PM EST or visit www.DrKids.com

Distributed by: CalmCo LLC, Sarasota, FL 34240

Made in Dominican Republic

Principal Display Panel

INGREDIENTS AND APPEARANCE

DR KIDS  COUGH AND CHEST CONGESTION
dextromethorphan hbr, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73282-2523
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY (Mixed Berry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73282-2523-2	18 in 1 POUCH	10/01/2025
1	NDC: 73282-2523-1	5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2	NDC: 73282-2523-3	30 in 1 POUCH	10/01/2025
2	NDC: 73282-2523-1	5 mL in 1 VIAL, SINGLE-DOSE; 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	10/01/2025

Labeler - CalmCo LLC (079308308)