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

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.

----------

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	Item Code (Source)	NDC: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
anhydrous citric acid
aspartame
FD&C yellow no. 6
aluminum oxide
magnesium stearate
maltodextrin
sorbitol

Product Characteristics
Color	ORANGE	Score	2 pieces
Shape	ROUND (Circular Flat Faced Tablet)	Size	12mm
Flavor	ORANGE	Imprint Code	DRAMAMINE
Contains

Packaging
#	Item Code	Package Description
1	NDC:50580-310-02	2 in 1 POUCH
2	NDC:50580-310-08	1 in 1 CARTON
2		8 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	10/01/2008	08/31/2013

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

Revised: 04/2012

Document Id: f1dc68e5-01c4-456e-97f0-0776308a78a3

Set id: 88c564ee-3687-4c5c-8dd1-65857dec3621

Version: 3

Effective Time: 20120430

McNeil Consumer Healthcare Div McNeil-PPC, Inc