1006-cardinal

SPL v7

SPL

SPL Set ID 7c4adbdb-9bce-0c9c-e053-2a91aa0a8107

Route

ORAL

Published

Effective Date 2021-11-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chlortheophylline (50 mg)

Inactive Ingredients

Croscarmellose Magnesium Stearate Dibasic Calcium Phosphate Dihydrate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

Imprint: 1006;1006 Shape: round Color: white Size: 9 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2019-01-04 Until 2029-02-28

Description

Active ingredient (in each tablet) Dimenhydrinate 50 mg

Medication Information

Warnings and Precautions

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

Description

Active ingredient (in each tablet) Dimenhydrinate 50 mg

Uses

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

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 42229-5

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

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

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

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product

■ marked drowsiness may occur

■ avoid alcoholic drinks

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ use caution when driving a motor vehicle or operating machinery

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland

Section 51727-6

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

Section 51945-4

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Antiemetic

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

Drug Facts

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Other 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

Questions Or Comments?

1-800-231-4670

Structured Label Content

Uses

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

Warnings and Precautions (34071-1)

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

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 42229-5 (42229-5)

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

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product

■ marked drowsiness may occur

■ avoid alcoholic drinks

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ use caution when driving a motor vehicle or operating machinery

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland

Section 51727-6 (51727-6)

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

Section 51945-4 (51945-4)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antiemetic

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

Drug Facts

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Other Information (Other 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

Questions Or Comments? (Questions or comments?)

1-800-231-4670

Advanced Ingredient Data

[{"name": "CROSCARMELLOSE", "unii": "029TFK992N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLORTHEOPHYLLINE", "unii": "GE2UA340FM", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness", "34071-1": "Do not give to children under 2 years of age unless directed by a doctor", "34088-5": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "42229-5": "*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", "50565-1": "Keep out of reach of children.", "50567-7": "When using this product ■ marked drowsiness may occur ■ avoid alcoholic drinks ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ use caution when driving a motor vehicle or operating machinery", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "50569-3": "Ask a doctor before use if you have ■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ trouble urinating due to an enlarged prostate gland", "51727-6": "croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose", "51945-4": "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", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Antiemetic", "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", "Drug Facts": "Active ingredient (in each tablet) Dimenhydrinate 50 mg", "Other 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", "Questions or comments?": "1-800-231-4670"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:31.534317 · Updated: 2026-03-14T23:13:51.825108