FDA.reportPublic FDA data

Motion Sickness Relief

Manufacturer
FRED'S, INC. | LNK International, Inc.
Effective date
2020-03-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:39:16

Label at a glance#

ProductMotion Sickness Relief
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

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; ...

Storage and handling

each tablet contains: calcium 35 mg see end flap for expiration date and lot number 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

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

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • 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,

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity
adults and children 12 years and over1 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 years½ 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 years½ tablet every 6-8 hours; do not exceed 1½ tablets in 24 hours, or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 35 mg
  • see end flap for expiration date and lot number
  • 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

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

fred's
Pharmacy

NDC 55315-198-02

*Compare to active ingredient in
Dramamine® Original Formula

ORIGINAL FORMULA
Motion Sickness Relief
Dimenhydrinate 50 mg • Antiemetic 

Prevents Nausea, Vomiting
& Dizziness for Children & Adults

12 TABLETS

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: fred's, Inc.
4300 NEW GETWELL RD., MEMPHIS, TN 38118
www.fredsinc.com

100%
satisfaction
guaranteed
Questions or comments:
1-855-331-FRED(3733)

Freds Pharmacy 44-198
Freds Pharmacy 44-198

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
55315-19855315-198-02

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

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
dcab8463-6d9b-4ab2-92d8-16ad0842a1785b080aee-e50f-4619-94b9-79937f2bdecc2021-01-26WarningsExact identifier
spl set id: 5b080aee-e50f-4619-94b9-79937f2bdecc

Reported adverse events (FAERS/openFDA)#

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