MedPath

Equate Kids Daytime Dex Cough Gels

Dextromethorphan HBr 10 mg

Approved
Approval ID

37269cd6-1528-9879-e063-6394a90a2b54

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 9, 2025

Manufacturers
FDA

Walmart

DUNS: 051957769

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dextromethorphan

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code79903-337
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dextromethorphan
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2025
FDA Product Classification

INGREDIENTS (2)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 10 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/1/2025

Equate Kids Daytime Dex Gel Chews 16ct

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/1/2025

Uses temporarily relieves:

  • cough due to minor throat and bronchial irritation as may occur with a cold

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/1/2025

Active ingredient (in each chewable tablet)

Dextromethorphan HBr 10 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/1/2025

Purpose

Cough suppressant

WARNINGS SECTION

LOINC: 34071-1Updated: 6/1/2025

Warnings

Do not use if you are now taking a prescription monoamine axidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 week after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 6/1/2025

When using this product do not exceed recommended dosage

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 6/1/2025

Ask a doctor before use if you have

  • a sodium-restricted diet
  • cough accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/1/2025

Keep out of reach of children.

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 6/1/2025

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/1/2025

Stop use and ask doctor if

  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 6/1/2025

If pregnant or breast-feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/1/2025

Directions

  • take every 4 hours or as directed by a doctor
  • chew thoroughly before swallowing

adults and children 12 years of age and over - 2 chewable tablets every 4 hours, not to exceed 12 chewable tablets in any 24-hour period

children ages 6 to 12 years - 1 chewable tablet every 4 hours, not to exceed 6 chewable tablets in any 24-hour period

children under 6 - do not use

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 6/1/2025

Other information

  • each chewable tablet contains:potassium 5 mg and sodium 15 mg
  • store in a cool, dry place at 20° - 25°C (68° to 77°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/1/2025

Inactive ingredients: Anhydrous citric acid, beta-carotene, corn syrup, glycerin, malic acid, medium chain triglycerides, natural & artificial flavors, pectin, sodium chloride, trisodium citrate (anhydrous), sucralose, sucrose, water.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/1/2025

Questions? 1-888-287-1915

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Equate Kids Daytime Dex Cough Gels - FDA Drug Approval Details