DRAMAMINE FOR KIDS - 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.

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Drug Facts

Active ingredient

(in each tablet)

Dimenhydrinate 25 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 the child has

a breathing problem such as emphysema or chronic bronchitis
glaucoma

Ask a doctor or pharmacist before use if the child is

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 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:

Children 2 to under 6 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 6 to under 12 years	give 1 to 2 chewable tablets every 6-8 hours do not give more than 6 chewable tablets in 24 hours, or as directed by a doctor

Other information

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

Inactive ingredients

aspartame, citric acid, flavor, magnesium stearate, methacrylic acid copolymer, sorbitol

Questions?

1-800-382-7219 Dramamine.com

PRINCIPAL DISPLAY PANEL

#1Pharmacist Recommended Brand
Ages 2 – 12
Safe, Precise Dose
Children’s Chewable Formula
Dramamine MOTION SICKNESS RELIEF for Kids
8 Chewable Tablets
Dye Free Grape Flavor

PRINCIPAL DISPLAY PANEL
#1Pharmacist Recommended Brand
Ages 2 – 12
Safe, Precise Dose
Children’s Chewable Formula
Dramamine MOTION SICKNESS RELIEF for Kids
8 Chewable Tablets
Dye Free Grape Flavor

DRAMAMINE FOR KIDS
dimenhydrinate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63029-904
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMENHYDRINATE (DIMENHYDRINATE)	DIMENHYDRINATE	25 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME
CITRIC ACID MONOHYDRATE
MAGNESIUM STEARATE
SORBITOL

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor	GRAPE	Imprint Code	DRA
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:63029-904-01	1 CASE (1 CASE) in 1 BLISTER PACK	contains a CASE
1		8 TABLET, CHEWABLE (8 TABLET) in 1 CASE	This package is contained within the BLISTER PACK (63029-904-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part336	02/15/2012

Labeler - Medtech Products Inc. (122715688)

Establishment
Name	Address	ID/FEI	Operations
Contract Pharmacal Corporation		057795122	MANUFACTURE

Revised: 02/2012 Medtech Products Inc.