1006-Major

Set ID
78d22836-a442-7c0c-e053-2991aa0a62f3
Manufacturer
Major Pharmaceuticals
Effective date
2025-08-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:12:10

Key Label Information

Active Ingredients And Purpose

Drug Facts

Active ingredient (in each tablet) Dimenhydrinate 50 mg

OTC - PURPOSE SECTION

Purpose Antiemetic

Uses

Uses

for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

Warnings

WARNINGS SECTION

Do not give to children under 2 years of age unless directed by a doctor

Directions And Dosage

Directions

■ to prevent motion sickness, the rst dose should be taken one-half to one hour before starting activity ■ adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor ■ children 6 to under 12 years of age : 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor ■ children 2 to under 6 years of age : 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

Other Label Information

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

Questions or comments?

1-800-231-4670

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR ® NDC 0904-6772-12 Compare to the Active Ingredient in DRAMAMINE ® Original Formula* Driminate TM Dimenhydrinate USP, Antiemetic For Nausea, Dizziness and Vomiting from Motion Sickness 12 Tablets 50mg Each Use as Directed

Products

NDC Codes

Ingredients

NameUNIIKind
DIMENHYDRINATEJB937PER5CACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

Complete SPL Sections

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Dimenhydrinate 50 mg

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose Antiemetic

Uses

INDICATIONS & USAGE SECTION

for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

WARNINGS SECTION

WARNINGS SECTION

Do not give to children under 2 years of age unless directed by a doctor

Directions

DOSAGE & ADMINISTRATION SECTION

■ to prevent motion sickness, the rst dose should be taken one-half to one hour before starting activity ■ adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor ■ children 6 to under 12 years of age : 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor ■ children 2 to under 6 years of age : 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

Other information

OTHER SAFETY INFORMATION

■ each tablet contains: calcium 30 mg ■ store in a dry place at 15° – 30°C (59° – 86°F) ■ protect from moisture ■ see end -ap for expiration date and lot number ■ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION *This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine®. Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Questions or comments? Call (800) 616-2471 www.majorpharmaceuticals.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR ® NDC 0904-6772-12 Compare to the Active Ingredient in DRAMAMINE ® Original Formula* Driminate TM Dimenhydrinate USP, Antiemetic For Nausea, Dizziness and Vomiting from Motion Sickness 12 Tablets 50mg Each Use as Directed

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc3c44729b-0a55-8eaf-e063-6394a90a5ba4.xml2025-08-31
otc1006-12BB-IFC R52064-.jpg2024-05-07
otc17cb14a2-2b96-a195-e063-6294a90afb79.xml2024-05-07
otcb4043aed-f29f-c266-e053-2995a90a1c58.xml2020-11-14
otc1006-12BB_label -.jpg2019-02-14
otc78d22836-a443-7c0c-e053-2991aa0a62f3.xml2019-02-14