Your browser does not support JavaScript! MOTION SICKNESS ORIGINAL FORMULA (DIMENHYDRINATE) TABLET [MCKESSON (SUNMARK)]
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MOTION SICKNESS ORIGINAL FORMULA (dimenhydrinate) tablet
[McKesson (Sunmark)]


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

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Uses

for the 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 an 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 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 1/2 to 1 hour before starting activity
 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 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 years1/4 to 1/2 tablet every 6-8 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-77ºF)

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 DRAMAMINE® ORIGINAL FORMULA ACTIVE INGREDIENT*

Helps to prevent nausea, vomiting or dizziness associated with motion sickness

Motion Sickness

Original Formula

For children & adults

DIMENHYDRINATE

ANTIEMETIC

FAST ACTING

TABLETS 50 mg EACH

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

Another Quality Product Distributed by McKesson

One Post Street, San Francisco, CA 94104

Please visit us at www.sunmarkbrand.com

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.

Package Label

Dimenhydrinate 50 mg

Sunmark Motion Sickness Tablet

 

MOTION SICKNESS  ORIGINAL FORMULA
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49348-070
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:49348-070-021 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33606/13/2011
Labeler - McKesson (Sunmark) (177667227)

Revised: 3/2014
 
McKesson (Sunmark)

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