MOTION SICKNESS RELIEF- dimenhydrinate tablet 
Cardinal Health 110, LLC. DBA Leader

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Leader 44-198

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Uses

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

Warnings

Do not use

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

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland 

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • avoid alcoholic beverages
  • marked drowsiness may occur
  • 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 (1-800-222-1222) right away. 

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		 1/2 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		 1/2 tablet every 6-8 hours; do not exceed 1 1/2
 tablets in 24 hours, or as directed by a doctor

Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid 

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC 70000-0250-1

Motion Sickness Relief
Dimenhydrinate, 50 mg | Antiemetic

Fast acting
Relief of Motion Sickness
for Children & Adults

12 TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

All LEADER™ Brand Products Have A
100% Money Back Guarantee
Return to place of purchase if not satisfied.

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

50844 ORG111519802

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

www.myleader.com     1-800-200-6313
Essential to Care™ since 1979

©2017 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

Leader 44-198

Leader 44-198

MOTION SICKNESS RELIEF 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0250
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M, CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code 44;198
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0250-12 in 1 CARTON12/01/199203/29/2021
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33612/01/199203/29/2021
Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(70000-0250)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(70000-0250)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(70000-0250)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088pack(70000-0250)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(70000-0250)

Revised: 4/2022
Document Id: d298707c-50e6-4ef5-a6c7-671791c301ff
Set id: 77b55f4c-2da1-4043-97b2-497bccec5974
Version: 8
Effective Time: 20220408
 
Cardinal Health 110, LLC. DBA Leader