DRAMAMINE  ORIGINAL FORMULA- dimenhydrinate tablet 
McNeil Consumer Healthcare Div McNeil-PPC, 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 50 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 you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged 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
  • be careful when driving a motor vehicle or operating machinery

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

  • 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:
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

  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or if blister unit is broken or torn
  • see side panel for lot number and expiration date

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-313
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimenhydrinate (Dimenhydrinate) Dimenhydrinate50 mg
Inactive Ingredients
Ingredient NameStrength
anhydrous lactose 
silicon dioxide 
croscarmellose sodium 
magnesium stearate 
cellulose, microcrystalline 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUND (Standard biconvex) Size9mm
FlavorImprint Code DRAMAMINE
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-313-121 in 1 BLISTER PACK
112 in 1 VIAL, PLASTIC
2NDC:50580-313-363 in 1 CARTON
212 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33610/01/200809/30/2013
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 04/2012
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc