DRAMAMINE- meclizine hydrochloride tablet, chewable

DRAMAMINE by

Drug Labeling and Warnings

DRAMAMINE 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 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 ingredients

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

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)

INGREDIENTS AND APPEARANCE

DRAMAMINE 
meclizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-906
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	PINK	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor	RASPBERRY (Raspberry cream)	Imprint Code	258
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-906-12	12 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/15/2019

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)