DRAMAMINE  ORIGINAL FORMULA - dimenhydrinate tablet 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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Dramamine®
ORIGINAL FORMULA

Drug Facts

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Use

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

• nausea
• vomiting
• dizziness

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
• trouble urinating due to an enlarged 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
• be careful 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. (1-800-222-1222)

Directions

• to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
• to prevent or treat motion sickness, see below:

adults and children 12 years and over	take 1 to 2 tablets every 4-6 hours do not take more than 8 tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years	give ½ to 1 tablet every 6-8 hours do not give more than 3 tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years	give ½ tablet every 6-8 hours do not give more than 1-1/2 tablets in 24 hours, or as directed by a doctor

Other information

• store between 20-25°C (68-77°F)
• do not use if carton is opened or if blister unit is broken or torn
• see side panel for lot number and expiration date

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose

Questions or comments?

call 1-800-382-7219

PRINCIPAL DISPLAY PANEL

NDC 50580-313-36

Dimenhydrinate Tablets/Antiemetic
Dramamine®
ORIGINAL FORMULA

Fast Acting Motion
Sickness Relief

For Children and Adults

36 TABLETS (50 mg EACH)

DRAMAMINE   ORIGINAL FORMULA dimenhydrinate   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 50580-313 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimenhydrinate (Dimenhydrinate) Dimenhydrinate 50 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score 2 pieces Shape ROUND (Standard biconvex) Size 9mm Flavor Imprint Code DRAMAMINE Contains

Packaging # NDC Package Description Multilevel Packaging 1 50580-313-12 1 VIAL In 1 BLISTER PACK contains a VIAL, PLASTIC 1 12 TABLET In 1 VIAL, PLASTIC This package is contained within the BLISTER PACK (50580-313-12) 2 50580-313-36 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 12 TABLET In 1 BLISTER PACK This package is contained within the CARTON (50580-313-36)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	10/01/2008

Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 09/2009McNeil Consumer Healthcare Div McNeil-PPC, Inc