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

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

Other information

• Phenylketonurics: contains phenylalanine 0.84 mg per tablet
• 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 citric acid, aspartame, FD&C yellow #6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol

Questions or comments?

call 1-800-382-7219

PRINCIPAL DISPLAY PANEL

NDC 50580-310-08

Dimenhydrinate Tablets/Antiemetic
Dramamine®
CHEWABLE FORMULA

Convenient Chewable Tablets
For Children and Adults.

8 ORANGE FLAVOR TABLETS (50 mg EACH)

DRAMAMINE   CHEWABLE FORMULA dimenhydrinate   tablet, chewable

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 50580-310 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 ORANGE Score 2 pieces Shape ROUND (Circular Flat Faced Tablet) Size 12mm Flavor ORANGE Imprint Code DRAMAMINE Contains

Packaging # NDC Package Description Multilevel Packaging 1 50580-310-02 2 TABLET In 1 POUCH None 2 50580-310-08 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 8 TABLET In 1 BLISTER PACK This package is contained within the CARTON (50580-310-08)

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