FDA.reportPublic FDA data

GoodSense 44-198

Manufacturer
Geiss, Destin & Dunn Inc. | LNK International, Inc.
Effective date
2026-06-15
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-07-15 00:32:53

Label at a glance#

ProductMotion Sickness
Active ingredientDIMENHYDRINATE
Label structure9 sections

Indications and uses

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

Dosage and administration

do not take more than directed to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity to prevent or treat motion sickness, see below: adults and children 12 years and over ■ take 1 to 2 tablets every 4-6 hours ■ do not take more than 8 tablets in    24 hours, or as directed by a doctor children 6 to under 12 years ■ give 1/2 to 1 tablet every 6-8 hours ■ do not give more ...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Dimenhydrinate 50 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

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

  • nausea
  • vomiting
  • dizziness

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.


Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity
  • to prevent or treat motion sickness, see below:
adults and children
12 years and over		■ take 1 to 2 tablets every 4-6 hours
■ do not take more than 8 tablets in
   24 hours, or as directed by a doctor
children 6 to under
12 years		■ give 1/2 to 1 tablet every 6-8 hours
■ do not give more than 3 tablets in
   24 hours, or as directed by a doctor
children 2 to under
6 years		■ give 1/2 tablet every 6-8 hours
■ do not give more than 1 1/2 tablets in
   24 hours, or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • 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 ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GoodSense®

NDC 50804-198-02

Original Formula

Motion Sickness
Dimenhydrinate 50 mg
Antiemetic

Prevents & Relieves Nausea, Vomiting & Dizziness
for Children & Adults

12 Tablets

Dye Free

actual size

*Compare to the active ingredient of
Dramamine® Original Formula
100% SATISFACTION
GUARANTEED

Goodsense 44-198Goodsense 44-198

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130846036000894GTIN-13: 0846036000894
EAN-13: 0846036000894
GTIN-12: 846036000894
UPC-A: 846036000894
GTIN storage (14 digits): 00846036000894		goodsense-44-198-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-198-02EA - Each50804-1982cbb69f4-31e6-49be-b9df-8a51600f3e2512023-09-05

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50804-19850804-198-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMENHYDRINATEJB937PER5CACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-11-15full-release2026-06-01 01:16:22

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
Motion SicknessDIMENHYDRINATEGeiss, Destin & Dunn Inc.fdb683c5-ff7f-4b93-9892-670cf1f29f2a2026-06-15WarningsExact identifier
ndc (package): 50804-198-02
ndc (product): 50804-198
ndc11 (package): 50804019802
spl id: b390491e-1730-429a-80ec-132db26bebfe
spl set id: fdb683c5-ff7f-4b93-9892-670cf1f29f2a

Reported adverse events (FAERS/openFDA)#

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