Package Insert and Label Information: Dramamine Orange

By Medtech Products Inc. | Last revised: 21 January 2012

DRAMAMINE ORANGE- dimenhydrinate tablet, chewable
Medtech Products 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 give to 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 d octor 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

I f pregnant or breast-feeding,

ask a doctor before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 chewable tabletsin 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 chewable tabletsin 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 ½ chewable tabletsin 24 hours, or as directed by a doctor

Other information

Phenylketonurics: contains phenylalanine 0.84 mg per tablet
store at room temperature 68-77ºF (20-25ºC)
do not use if carton is opened or if blister 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

Dimenhydrinate Tablets/Antiemetic
CHEWABLE FORMULA
Dramamine^®
MOTION SICKNESS RELIEF
DUAL ACTION
1. TREATS SYMPTOMS ON THE SPOT
2. PREVENTS NAUSEA, DIZZINESS & VOMITING
Convenient Chewable Tablets8 ORANGE FLAVORED TABLETS (50 mg EACH)

(click image for full-size original)

DRAMAMINE ORANGE dimenhydrinate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63029-902
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	Size	12mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:63029-902-01	1 BLISTER PACK (1 BLISTER) in 1 BOX	contains a BLISTER PACK
1		8 TABLET, CHEWABLE (8 TABLET) in 1 BLISTER PACK	This package is contained within the BOX (63029-902-01)
2	NDC:63029-902-02	2 TABLET, CHEWABLE (2 TABLET) in 1 POUCH	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part336	01/15/2012

Labeler — Medtech Products Inc. (122715688)

Establishment
Name	Address	ID/FEI	Operations
Contract Pharmacal Corporation		057795122	ANALYSIS, LABEL, MANUFACTURE, PACK

Revised: 01/2012 Medtech Products Inc.