DRAMAMINE: Package Insert and Label Information

DRAMAMINE- meclizine hydrochloride tablet, chewable
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 give to

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

■to prevent motion sickness take first dose ½ hour to 1 hour before activity that may result in nausea

■to treat motion sickness, take at first signs of symptoms

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

croscarmellose sodium, crospovidone, FD&C red #40 lake, lactose, magnesium stearate, raspberry flavor, silica, sodium saccharin, stearic acid, vanilla flavor

Questions?

1-800-382-7219

P RINCIPAL DISPLAY PANEL

All Day Less Drowsy Chewable Formula

Dramamine®

Meclizine HCl 25 mg /Motion Sickness Relief

12 Raspberry Cream Flavored Chewable Tablets (25mg EACH)

PRINCIPAL DISPLAY PANEL

All Day Less Drowsy Chewable Formula

Dramamine®
Meclizine HCl 25 mg /Motion Sickness Relief

12 Raspberry Cream Flavored Chewable Tablets (25mg EACH)
(click image for full-size original)

DRAMAMINE
meclizine hydrochloride tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-906
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
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FD&C RED NO. 40
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
SILICON DIOXIDE
SACCHARIN SODIUM
STEARIC ACID
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND Size 9mm
Flavor RASPBERRY (Raspberry cream) Imprint Code 258
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-906-12 12 TABLET, CHEWABLE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part336 02/15/2019
Labeler — Medtech Products Inc. (122715688)

Revised: 07/2019 Medtech Products Inc.

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