FDA.reportPublic FDA data

DrKids Cough and Chest Congestion (LA)

Manufacturer
CalmCo LLC
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
weekly-update
Hydrated at
2026-07-17 21:43:38

Label at a glance#

ProductDr Kids Cough and Chest Congestion
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

.

Active Ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

.

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 4consult a doctor
4 to under 61 vial every 4 hours
6 to under 121-2 vials every 4 hours
12 and older2-4 vials every 4 hours

Other information

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

+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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73282-252373282-2523-1, 73282-2523-2, 73282-2523-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SUCRALOSE96K6UQ3ZD4IACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
SACCHARIN SODIUMSB8ZUX40TYIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-10-02full-release2026-06-01 01:15:34

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
Dr Kids Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINCalmCo LLC3f156679-7a91-aff1-e063-6394a90a18f62026-03-31WarningsExact identifier
ndc (package): 73282-2523-3
ndc (package): 73282-2523-1
ndc (package): 73282-2523-2
ndc (product): 73282-2523
ndc11 (package): 73282252301
ndc11 (package): 73282252303
ndc11 (package): 73282252302
spl id: 4e58ce73-3c59-7b28-e063-6394a90a5d8c
spl set id: 3f156679-7a91-aff1-e063-6394a90a18f6

Reported adverse events (FAERS/openFDA)#

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