DIMENHYDRINATE - dimenhydrinate tablet
Contract Pharmacal Corp

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.

----------

Dimenhydrinate

SPL UNCLASSIFIED

*Compare to the active ingredient in Dramamine® Tablets

Dimenhydrinate 50mg

MOTION SICKNESS RELIEF for ADULTS and CHILDREN

100 Tablets

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

Active Ingredient

(in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Uses

for prevention and treatment of these symptoms associated with motion sickness

nausea
vomiting
dizziness

Warnings

Do not use

in children under 2 years of age unless directed by a doctor

Ask a doctor before use if you have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the 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
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and over	1 to 2 tablets every 4 to 6 hours, not to exceed 12 tablets in 24 hours
children 6 years to under 12 years of age	½ to 1 tablet every 6 to 8 hours, not to exceed 3 tablets in 24 hours
children 2 years to under 6 years of age	¼ to ½ tablet every 6 to 8 hours, not to exceed 1 ½ tablets in 24 hours
children under 2 years of age	consult a doctor

To prevent motion sickness, the first dose should be taken one half to one hour before starting activity.
DO NOT EXCEED RECOMMENDED DOSE

Other information: store at room temperature, USP

Each tablet contains 29 mg of calcium

Inactive ingredients

Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate and Microcrystalline Cellulose.

*This product is not manufactured or distributed by Pfizer Consumer Healthcare owner of the registered trademark Dramamine® Tablets.

Manufactured by: CONTRACT PHARMACAL CORP.
135 Adams Ave., Hauppauge, NY 11788 USA / www.CPCHealth.com

02/08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DIMENHYDRINATE
dimenhydrinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10267-1006
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMENHYDRINATE (UNII: JB937PER5C) (DIMENHYDRINATE - UNII:JB937PER5C)	DIMENHYDRINATE	50 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	1006;1006
Contains

#	Item Code	Package Description
Packaging
1	NDC:10267-1006-1	100 in 1 BOTTLE
2	NDC:10267-1006-4	1000 in 1 BOTTLE
3	NDC:10267-1006-0	12 in 1 CASE
3		12 in 1 BLISTER PACK

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part336	01/12/2001

Labeler - Contract Pharmacal Corp (968334974)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp		968334974	MANUFACTURE

Revised: 11/2011

Document Id: c82df322-fce0-4bfa-b21b-a2e921611d81

Set id: 14ccdb11-5706-4007-aa27-a60ef3f09ce7

Version: 1

Effective Time: 20111117

Contract Pharmacal Corp