MedPath

Dramamine for Kids

Dramamine for Kids

Approved
Approval ID

12bc3f17-ed62-4d0d-9b1e-3835579e711b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 10, 2025

Manufacturers
FDA

Medtech Products Inc.

DUNS: 122715688

Products 1

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

Dimenhydrinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63029-904
Application NumberM009
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dimenhydrinate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 10, 2025
FDA Product Classification

INGREDIENTS (5)

DIMENHYDRINATEActive
Quantity: 25 mg in 1 1
Code: JB937PER5C
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/10/2025

PRINCIPAL DISPLAY PANEL

#1Pharmacist Recommended Brand****
Ages 2 – 12****
Safe, Precise Dose****
Children’s Chewable Formula****
Dramamine MOTION SICKNESS RELIEF for Kids****
8 Chewable Tablets****
Dye Free Grape Flavor

![PRINCIPAL DISPLAY PANEL #1Pharmacist Recommended Brand Ages 2 – 12 Safe, Precise Dose Children’s Chewable Formula Dramamine MOTION SICKNESS RELIEF for Kids 8 Chewable Tablets Dye Free Grape Flavor](/dailymed/image.cfm?name=dramamine-for- kids-01.jpg&id=896889)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/10/2025

Use

for prevention and treatment of these symptoms associated with motion sickness:

  • nausea

  • vomiting

  • dizziness

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/10/2025

Purpose

Antiemetic

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/10/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/10/2025

Active ingredient

(in each tablet)

Dimenhydrinate 25 mg

WARNINGS SECTION

LOINC: 34071-1Updated: 9/10/2025

Warnings

Do not use for

children under 2 years of age unless directed by a doctor

Ask a doctor before use if****the child has

  • a breathing problem such as emphysema or chronic bronchitis

  • glaucoma

Ask a doctor or pharmacist before use if the****child is

taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur

  • avoid alcoholic drinks

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

ask a doctor before use.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/10/2025

Directions

  • to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity

  • to prevent or treat motion sickness, see below:

Children 2****
to under 6****
years

  • give ½ to 1 chewable tablet every 6-8 hours

  • do not give more than 3 chewable tablets
    in 24 hours, or as directed by a doctor

Children 6****
to under 12****
years

  • give 1 to 2 chewable tablets every 6-8 hours

  • do not give more than 6 chewable tablets in
    24 hours, or as directed by a doctor

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/10/2025

Other information

  • Phenylketonurics: contains phenylalanine 0.84 mg per tablet

  • store at room temperature 68º - 77ºF (20º - 25ºC)

*do not use if blister is broken or torn

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/10/2025

Inactive ingredients

aspartame, citric acid, flavor, magnesium stearate, methacrylic acid copolymer, sorbitol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/10/2025

Questions?

1-800-382-7219 Dramamine.com

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