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.

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Dramamine-N Nausea

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

PRINCIPAL DISPLAY PANEL

Dramamine®-N
Meclizine Hydrochloride Tablets/Antiemetic

10 Tablets

DRAMAMINE - N 
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-905
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOWScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-905-102 in 1 BOX01/15/2018
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33601/15/2018
Labeler - Medtech Products Inc. (122715688)

Revised: 2/2019
Document Id: 1b472f88-a518-4643-b4d8-e94e7f748149
Set id: 7fec7791-c242-4e43-8184-32820e657afb
Version: 1
Effective Time: 20190225
 
Medtech Products Inc.