DRAMAMINE LESS DROWSY FORMULA- meclizine hydrochloride 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)

Meclizine HCl 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 12 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 enlarged prostate gland

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

When using this product

  • 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

  • take first dose one hour before starting activity
  • adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor

Other information

  • store between 20 – 25°C (68 – 77°F)
  • do not use if blister is broken or torn

Inactive ingredients

anhydrous lactose, corn starch, colloidal silicon dioxide, D&C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose

Questions or comments?

call 1-800-382-7219

PRINCIPAL DISPLAY PANEL

NDC 50580-312-08

Meclizine hydrochloride tablets/Antiemetic
Dramamine®
LESS DROWSY FORMULA

Provides Up To 24 Hours of Motion Sickness Protection
Protection With Less Drowsiness!

8 TABLETS (25 mg EACH)

PRINCIPAL DISPLAY PANEL
DRAMAMINE LESS DROWSY FORMULA 
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-312
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Meclizine Hydrochloride (Meclizine) Meclizine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
anhydrous lactose 
starch, corn 
silicon dioxide 
D&C yellow NO. 10 
aluminum oxide 
magnesium stearate 
cellulose, microcrystalline 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUND (Flat faced bevelled edge) Size9mm
FlavorImprint Code DRAMAMINE
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-312-081 in 1 BLISTER PACK
18 in 1 VIAL, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33612/01/200804/30/2013
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 04/2012
Document Id: 57d9067b-1f0b-4e3f-9647-583b24f50e3f
Set id: 636e4941-b51c-4ed1-92c2-ced3b5c92005
Version: 3
Effective Time: 20120430
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc