ORIGINAL FORMULA MOTION SICKNESS RELIEF- dimenhydrinate tablet 
Cardinal Health (Leader) 37205

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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Drug Facts

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

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

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

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.

Directions

  • to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity
 adults and children 12 years 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  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  1/4 to 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

  • each tablet contains: calcium 30 mg
  • store at room temperature 20º-25ºC (68º-77ºF)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

Principal Display Panel

Compare to Dramamine® Original Formula* active ingredient

ORIGINAL FORMULA

Motion Sickness Relief Tablets

Dimenhydrinate 50 mg

Antiemetic

For Adults and Children

TABLETS - 50 MG EACH

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Original Formula.

DISTRIBUTED BY CARDINAL HEALTH,

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

Dimenhydrinate 50 mg

Leader Original Formula Motion Sickness Relief Tablets

ORIGINAL FORMULA MOTION SICKNESS RELIEF 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-111
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE) Score2 pieces
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 1006;1006
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-111-531 in 1 BOX06/26/201206/30/2020
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33606/26/201206/30/2020
Labeler - Cardinal Health (Leader) 37205 (097537435)

Revised: 7/2019
Document Id: 63017ffb-a85f-4caa-a496-107c2b5c646e
Set id: c560cb48-6de1-45f6-a850-6860ea9b0497
Version: 5
Effective Time: 20190711
 
Cardinal Health (Leader) 37205