FDA.reportPublic FDA data

DrKids Childrens Cough and Chest Congestion DM

Manufacturer
CalmCo LLC
Effective date
2024-05-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:12:59

Label at a glance#

ProductDrKids Childrens Cough and Chest Congestion DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure8 sections

Indications and 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

Dosage and administration

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 Char t 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...

Label contents#

Full prescribing information#

Active Ingredient (in each 5mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP, 5mg

Guaifenesin, USP, 100mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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 yearsConsult 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

INACTIVE INGREDIENT SECTION

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

Other information

OTHER SAFETY 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?

OTC - QUESTIONS SECTION

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

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73282-0013DRKIDS CHILDRENS COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CALMCO LLC]5Legacy NDC20240526_c8d73754-5efe-6bd4-e053-2a95a90a3d2f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73282-001373282-0013-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
WATER059QF0KO0RIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SORBITOL506T60A25RIACT
GUAIFENESIN495W7451VQACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1934fe44-8c2d-a796-e063-6294a90a52f9c8d73754-5efe-6bd4-e053-2a95a90a3d2f2024-05-24WarningsExact identifier
spl id: 1934fe44-8c2d-a796-e063-6294a90a52f9
spl set id: c8d73754-5efe-6bd4-e053-2a95a90a3d2f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.