DIMENHYDRINATE tablet, film coated

DIMENHYDRINATE by

Drug Labeling and Warnings

DIMENHYDRINATE by is a Otc medication manufactured, distributed, or labeled by Time Cap Labs, Inc, Time Cap Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

EACH TABLET CONTAINS DIMENHYDRINATE 50 MG

INACTIVE INGREDIENT

COLLOIDAL SILICON DIOXIDE, CROSCARMELLOSE SODIUM,HYPROMELLOSE, AHNYDROUS LACTOSE, MAGNESIUM STEARATE, CELLULOSE, MICROCRYSTALLINE, MINEROL

PURPOSE

Antiemetic

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

irections:

To prevent motion sickness, the first dose should be taken one-half to one hour before starting activity.

Adults and children 12 years of age and over - 1 to 2 tablets every 4 to 6 hours, not to exceed 8 tablets in 24 hours, or as directed by a doctor

Children 6 to under 12 years of age 1/2 to 1 tablet every 6 to 8 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor

Children 2 to under 6 years of age - 1/4 to 1/2 tablet every 6 to 8 hours,not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

WARNINGS

Warnings

Do not use for children under 2 years of age unless directed by a doctor

INDICATIONS & USAGE

 

Use

for prevention and treatment of these symptoms associated with motion sickness:

nauseavomitingdizziness

ASK DOCTOR

Ask a doctor before use if you have glaucoma; a breathing problem such as emphysema or chronic bronchitis; difficulty in urination due to an enlargement of the prostate gland.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

WHEN USING

When using this product: do not exceed recommended dosage; marked drowsiness may occur; avoid alcoholic drinks; alcohol, sedatives, and tranquilizers may increase drowsiness.  Be careful when driving a motor vehicle or operating machinery.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use. 

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIMENHYDRINATE  
dimenhydrinate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-352
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIMENHYDRINATE	50 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	TCL;352
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-352-36	36 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	01/28/2011

Labeler - Time Cap Labs, Inc (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Labs, Inc.		037052099	manufacture(49483-352)