DRAMAMINE - N- meclizine hydrochloride tablet

DRAMAMINE - N by

Drug Labeling and Warnings

DRAMAMINE - N 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 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 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 activity that may result in nausea

■ adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor

Other information

■ store at room temperature 20°–25°C (68°-77°F) 

Inactive ingredients

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

Questions?

1-800-382-7219 Dramamine.com

PRINCIPAL DISPLAY PANEL

Dramamine®-N

Meclizine Hydrochloride Tablets/Antiemetic

10 Tablets

INGREDIENTS AND APPEARANCE

DRAMAMINE - N 
meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-905
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)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (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: 63029-905-10	2 in 1 BOX	01/15/2018
1		5 in 1 BLISTER PACK; 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	01/15/2018

Labeler - Medtech Products Inc. (122715688)