1006-Cardinal

Set ID
7c4adbdb-9bce-0c9c-e053-2a91aa0a8107
Manufacturer
LEADER/ Cardinal Health 110, Inc.
Effective date
2026-02-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:46:48

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 first 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

LEADER NDC 7000-0404-1 Original Formula Motion Sickness Relief Dimenhydrinate, 50 mg/ Antiemetic COMPARE TO DRAMAMINE® ORIGINAL FORMULA active ingredient* Fast Acting Motion Sickness Relief for Children & Adults 12 Tablets

Products

NDC Codes

Ingredients

NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
DIMENHYDRINATEJB937PER5CACTIB
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 first 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 flap 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

*This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine® KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION ©2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 All LEADER™ Brand Products Have A 100% Money Back Guarantee

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER NDC 7000-0404-1 Original Formula Motion Sickness Relief Dimenhydrinate, 50 mg/ Antiemetic COMPARE TO DRAMAMINE® ORIGINAL FORMULA active ingredient* Fast Acting Motion Sickness Relief for Children & Adults 12 Tablets

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc4b4343e5-4d4d-6a4a-e063-6394a90ad2bc.xml2026-02-22
otc2dd0a152-dd50-b2f3-e063-6294a90a93b9.xml2025-02-12
otc0fa22aa2-466a-6f8e-e063-6294a90a53f4.xml2024-01-24
otc1006-12BB-Leader- R50592.jpg2021-11-19
otcd114a2fc-8171-0aeb-e053-2a95a90a743e.xml2021-11-19
otcc4fcd6f9-c164-b923-e053-2a95a90acb1a.xml2021-06-19
otcb4043aed-f29c-c266-e053-2995a90a1c58.xml2020-11-14
otc1006-12BB.jpg2019-01-10
otc7c4adbdb-9bcf-0c9c-e053-2a91aa0a8107.xml2019-01-10