DRAMAMINE  ORIGINAL FORMULA - dimenhydrinate tablet 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

----------

Dramamine®
ORIGINAL FORMULA

Drug Facts

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Use

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

Warnings

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

Ask a doctor before use if you have

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

When using this product

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

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

Directions

adults and children 12 years and over
  • take 1 to 2 tablets every 4-6 hours
  • do not take more than 8 tablets in 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 tablets in 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 1-1/2 tablets in 24 hours, or as directed by a doctor

Other information

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose

Questions or comments?

call 1-800-382-7219

PRINCIPAL DISPLAY PANEL

NDC 50580-313-36

Dimenhydrinate Tablets/Antiemetic
Dramamine®
ORIGINAL FORMULA

Fast Acting Motion
Sickness Relief

For Children and Adults

36 TABLETS (50 mg EACH)

Principal Display Panel

DRAMAMINE   ORIGINAL FORMULA
dimenhydrinate   tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 50580-313
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
No Inactive Ingredients Found
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (Standard biconvex) Size 9mm
Flavor Imprint Code DRAMAMINE
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 50580-313-12 1 VIAL In 1 BLISTER PACK contains a VIAL, PLASTIC
1 12 TABLET In 1 VIAL, PLASTIC This package is contained within the BLISTER PACK (50580-313-12)
2 50580-313-36 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK
2 12 TABLET In 1 BLISTER PACK This package is contained within the CARTON (50580-313-36)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part336 10/01/2008

Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)
Revised: 09/2009 McNeil Consumer Healthcare Div McNeil-PPC, Inc