Your browser does not support JavaScript! MOTION SICKNESS RELIEF ORIGINAL FORMULA (DIMENHYDRINATE) TABLET [CARE ONE (AMERICAN SALES COMPANY)]
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MOTION SICKNESS RELIEF ORIGINAL FORMULA (dimenhydrinate) tablet
[Care One (American Sales Company)]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

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

  • a breathing problem  such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery

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

  • to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
adults and children 12 years and over1 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 yearstake 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 yearstake 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

  • each tablet contains: calcium 30 mg
  • store at room temperature 20o- 25oC (68o - 77o F)

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-630
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (DIPHENHYDRAMINE) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code 1006;1006
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-630-121 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33607/15/2010
Labeler - Care One (American Sales Company) (809183973)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
 
Care One (American Sales Company)

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