Drkids Children’s Cough & Chest Congestion Dm

Drkids Children’s Cough & Chest Congestion Dm
SPL v5
SPL
SPL Set ID c8d73754-5efe-6bd4-e053-2a95a90a3d2f
Route
ORAL
Published
Effective Date 2021-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg)
Inactive Ingredients
Water Trisodium Citrate Dihydrate Sorbitol Citric Acid Monohydrate Saccharin Sodium Sucralose Xanthan Gum Sodium Benzoate Glycerin Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-15 Until 2025-10-31
Description

Dextromethorphan HBr, USP, 5mg Guaifenesin, USP, 100mg

Purpose

Cough suppressant Expectorant

Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr, USP, 5mg Guaifenesin, USP, 100mg

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
Section 34088-5

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

Package

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





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.

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
Inactive Ingredients

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

Questions Or Comments?

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

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.

Active Ingredient (in Each 5ml)

Dextromethorphan HBr, USP, 5mg

Guaifenesin, USP, 100mg

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).

Structured Label Content

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
Section 34088-5 (34088-5)

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

Package

Purpose

Cough suppressant

Expectorant

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





Do Not Use (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.

Other Information (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
Inactive Ingredients

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

Questions Or Comments? (Questions or comments?)

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

Stop Use and Ask A Doctor If (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.

Active Ingredient (in Each 5ml) (Active Ingredient (in each 5mL))

Dextromethorphan HBr, USP, 5mg

Guaifenesin, USP, 100mg

Ask A Doctor Before Use If Your Child Has (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).

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:07.170639 · Updated: 2026-03-14T23:02:59.869199