MOTION SICKNESS RELIEF ORIGINAL FORMULA- dimenhydrinate tablet 
Care One (American Sales Company)

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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Dimenhydrinate 50 mg

Drug Facts

Active Ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Uses

for prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.

Warnings
Do not use

for children under 2 years of age, unless directed by a doctor

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over 1 to 2 tablets every 4- 6 hours; not to exceed 8 tablets in 24 hours or as directed by a doctor
children 6 to under 12 years take 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours or as directed by a doctor
 children 2 to under 6 years take 1/4 to 1/2 tablet every 6 to 8 hours; not to exceed 1- 1/2 tablets in 24 hours or as directed by a doctor.

Other information

Inactive ingredients

Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose.

Questions or comments?

Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

PRINCIPAL DISPLAY PANEL

Compare to Active Ingredient in Dramamine® *

Original Formula

Motion Sickness Relief

Dimenhydrinate tablets/ Antiemetic

Fast acting tablets

For children and adults

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Original Formula

Distributed by: FOODHOLD U.S.A LLC

LANDOVER, MD 20785

1-877-846-9949

© 2014 Ahold Licensing, Sarl

Quality guaranteed or your money back

Product Label

CareOne

Dimenhydrinate 50 mg tablets

MOTION SICKNESS RELIEF  ORIGINAL FORMULA
dimenhydrinate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-630
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE 50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code 1006;1006
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-630-12 1 in 1 CARTON
1 12 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part336 07/15/2010
Labeler - Care One (American Sales Company) (809183973)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
Document Id: 6642f605-701c-4943-894e-304888cff191
Set id: 3fd4f345-eb87-45b1-8536-eeb6fb8ce89a
Version: 2
Effective Time: 20121227
 
Care One (American Sales Company)