MedPath

Motion Sickness Relief

Good Neighbor Pharmacy 44-198

Approved
Approval ID

c4077301-db6c-473d-beb3-232d7134a13a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 2, 2025

Manufacturers
FDA

Amerisource Bergen

DUNS: 007914906

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 Code46122-536
Application NumberM009
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dimenhydrinate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (7)

DIMENHYDRINATEActive
Quantity: 50 mg in 1 1
Code: JB937PER5C
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/2/2025

Principal display panel

GOOD
** NEIGHBOR**
** PHARMACY****®**

NDC 46122-536-53

Compare to Dramamine® Original
Formula active ingredient*

Motion Sickness Relief

dimenhydrinate 50 mg / antiemetic

Original Formula

Prevents Nausea, Vomiting & Dizziness
Children & Adults

12 Tablets | 50 mg Each

Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
** UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING**

*This product is not manufactured or distributed
by Medtech Products Inc., owner of the registered
trademark Dramamine® Original Formula.

50844 ORG051819802

Distributed By
AmerisourceBergen
1 West First Avenue
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.com

![44-198](/dailymed/image.cfm?name=good-neighbor- pharmacy-44-198-1.jpg&id=895839)

44-198

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/8/2025

Uses

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

  • nausea
  • vomiting
  • dizziness

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/8/2025

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/8/2025

Purpose

Antiemetic

WARNINGS SECTION

LOINC: 34071-1Updated: 3/8/2025

Warnings

Do not use

for children under 2 years of age unless directed by a doctor.

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/8/2025

Directions

  • to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity

adults and children 12 years and over

1 to 2 tablets every 4-6 hours; do not exceed 8 tablets in 24 hours, or as directed by a doctor

children 6 to under 12 years

½ to 1 tablet every 6-8 hours; do not exceed 3 tablets in 24 hours, or as directed by a doctor

children 2 to under 6 years

½ tablet every 6-8 hours; do not exceed 1½ tablets in 24 hours, or as directed by a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 3/8/2025

Other information

*each tablet contains: calcium 35 mg *TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/8/2025

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 3/8/2025

Questions or comments?

1-800-426-9391

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Motion Sickness Relief - FDA Drug Approval Details