Leader 44-198

Leader 44-198
SPL v1
SPL
SPL Set ID ce83a868-bdd8-4c77-9bc0-664133028f75
Route
ORAL
Published
Effective Date 2025-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
8-chlorotheophylline (50 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 44;198 Shape: round Color: white Size: 9 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-05

Description

Dimenhydrinate 50 mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Dimenhydrinate 50 mg

Uses

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

  • nausea 
  • vomiting 
  • dizziness

Directions
  • 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; do not exceed 1½ tablets in 24 hours, or as directed by a doctor
Do Not Use

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

Other Information
  • 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

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

Questions Or Comments?

1-800-426-9391

Principal Display Panel

NDC 70000-0749-1

LEADER

Original Formula

Motion Sickness Relief

Dimenhydrinate, 50 mg | Antiemetic

Prevents Nausea,

Vomiting & Dizziness

for Children & Adults

12 TABLETS

Actual Size

COMPARE TO

DRAMAMINE®

ORIGINAL FORMULA

active ingredient*

100% Money Back Guarantee

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

100%

Money Back

Guarantee

Return to place of purchase.

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

©2025 Cardinal Health. All Rights

Reserved. CARDINAL HEALTH, the

Cardinal Health LOGO, ESSENTIAL TO

CARE, LEADER, and the LEADER LOGO

are trademarks or registered

trademarks of Cardinal Health. All

other marks are the property of their

respective owners.

Leader 44-198
When Using This Product
  • 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,

ask a health professional before use.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

Dimenhydrinate 50 mg

Ask A Doctor Before Use If You Have
  • 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

taking sedatives or tranquilizers.


Structured Label Content

Uses

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

  • nausea 
  • vomiting 
  • dizziness

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 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; do not exceed 1½ tablets in 24 hours, or as directed by a doctor
Do Not Use (Do not use)

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

Other Information (Other information)
  • 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 ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

NDC 70000-0749-1

LEADER

Original Formula

Motion Sickness Relief

Dimenhydrinate, 50 mg | Antiemetic

Prevents Nausea,

Vomiting & Dizziness

for Children & Adults

12 TABLETS

Actual Size

COMPARE TO

DRAMAMINE®

ORIGINAL FORMULA

active ingredient*

100% Money Back Guarantee

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

100%

Money Back

Guarantee

Return to place of purchase.

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

©2025 Cardinal Health. All Rights

Reserved. CARDINAL HEALTH, the

Cardinal Health LOGO, ESSENTIAL TO

CARE, LEADER, and the LEADER LOGO

are trademarks or registered

trademarks of Cardinal Health. All

other marks are the property of their

respective owners.

Leader 44-198
When Using This Product (When using this product)
  • 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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Dimenhydrinate 50 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • 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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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