Medication Guide App

Dramamine Less Drowsy Formula

Dosage form: tablet
Ingredients: Meclizine Hydrochloride 25mg
Labeler: McNeil Consumer Healthcare Div McNeil-PPC, Inc
NDC Code: 50580-312

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.

Dramamine®
LESS DROWSY FORMULA

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)

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 VIAL, PLASTIC in 1 BLISTER PACK
18 TABLET 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
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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