ORIGINAL FORMULA MOTION SICKNESS RELIEF- dimenhydrinate tablet

Original Formula Motion Sickness Relief by

Drug Labeling and Warnings

Original Formula Motion Sickness Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health (Leader) 37205. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Leader Original Formula Motion Sickness Relief Tablets

INGREDIENTS AND APPEARANCE

ORIGINAL FORMULA MOTION SICKNESS RELIEF 
dimenhydrinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-111
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIMENHYDRINATE	50 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	9mm
Flavor		Imprint Code	1006;1006
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-111-53	1 in 1 BOX	06/26/2012	06/30/2020
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part336	06/26/2012	06/30/2020

Labeler - Cardinal Health (Leader) 37205 (097537435)