DRAMAMINE FOR KIDS- dimenhydrinate tablet, chewable

Dramamine for Kids by

Drug Labeling and Warnings

Dramamine for Kids by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc., Contract Pharmacal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

DRAMAMINE FOR KIDS 
dimenhydrinate tablet, chewable

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIMENHYDRINATE	25 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SORBITOL (UNII: 506T60A25R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-904-01	1 in 1 BLISTER PACK
1		8 in 1 CASE

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	Business Operations
Contract Pharmacal Corporation		057795122	MANUFACTURE(63029-904)