Dr Kids
DrKids Children's Cough and Chest Congestion (A)
3f156679-7a91-aff1-e063-6394a90a18f6
HUMAN OTC DRUG LABEL
Sep 26, 2025
CalmCo LLC
DUNS: 079308308
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dextromethorphan HBr, Guaifenesin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel
INDICATIONS & USAGE SECTION
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
SPL UNCLASSIFIED SECTION
Drug Facts
.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient and Purpose
.
|
Active ingredient (in each 5 mL vial) |
Purpose |
|
Dextromethorphan HBr 5mg.............. |
Cough supressant |
|
Guaifenesin 100mg............ |
Expectorant |
WARNINGS SECTION
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).
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
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 INGREDIENT SECTION
Inactive ingredients
anhydrous citric acid, carboxymethylcellulose, flavor, propylene glycol, sodium benzoate, saccharin sodium, sorbitol, sucralose, water
OTC - QUESTIONS SECTION
Questions or comments?
+1-941-202-3270 (M-F) 9AM-5PM EST or visit www.DrKids.com
Distributed by: CalmCo LLC, Sarasota, FL 34240Made in Dominican Republic