DRAMAMINE LESS DROWSY- meclizine hydrochloride tablet

Dramamine Less Drowsy by

Drug Labeling and Warnings

Dramamine Less Drowsy by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

(in each tablet)

Meclizine HCI 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 an 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 doctor before use.

Keep out of reach of children.

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

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 - 25ºC (68 - 77ºF)
  
• do not use if blister is broken or torn

Inactive ingredients

corn starch, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, lactose, magnesium stearate, microcrystalline cellulose

Questions?

1-800-382-7219

PRINCIPAL DISPLAY PANEL

All Day LESS DROWSY
Dramamine®
Meclizine hydrochloride tablets/Antiemetic

8 TABLETS (25 mg EACH)

INGREDIENTS AND APPEARANCE

DRAMAMINE LESS DROWSY 
meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-903
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	YELLOW	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-903-01	1 in 1 BLISTER PACK	09/01/2011
1		8 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part336	09/01/2011

Labeler - Medtech Products Inc. (122715688)