DRAMAMINE – N: Package Insert and Label Information

DRAMAMINE — N- meclizine hydrochloride tablet
Medtech Products 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.

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 i ngredients

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

P RINCIPAL D ISPLAY P ANEL

Dramamine® -N

Meclizine Hydrochloride Tablets/Antiemetic

10 Tablets

PRINCIPAL DISPLAY PANEL

Dramamine®-N
Meclizine Hydrochloride Tablets/Antiemetic

10 Tablets
(click image for full-size original)

DRAMAMINE — N
meclizine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-905
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
STARCH, CORN
SILICON DIOXIDE
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-905-10 2 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 5 TABLET in 1 BLISTER PACK This package is contained within the BOX (63029-905-10)
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)

Revised: 02/2019 Medtech Products Inc.

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