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Dimenhydrinate by Contract Pharmacal Corp

Dosage form: tablet
Ingredients: DIMENHYDRINATE 50mg
Labeler: Contract Pharmacal Corp
NDC Code: 10267-1006

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.

Dimenhydrinate

SPL UNCLASSIFIED

*Compare to the active ingredient in Dramamine® Tablets

Dimenhydrinate 50mg

MOTION SICKNESS RELIEF for ADULTS and CHILDREN

100 Tablets

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

Active Ingredient

(in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Uses

for prevention and treatment of these symptoms associated with motion sickness

  • nausea
  • vomiting
  • dizziness

Warnings

Do not use

  • in children under 2 years of age unless directed by a doctor

Ask a doctor before use if you have
  • glaucoma
  • a breathing problem  such as emphysema or chronic bronchitis
  • 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
  • excitability may occur, especially in children

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 of age and over1 to 2 tablets every 4 to 6 hours, not to exceed 12 tablets in 24 hours
children 6 years to under 12 years of age½ to 1 tablet every 6 to 8 hours, not to exceed 3 tablets in 24 hours
children 2 years to under 6 years of age¼ to ½ tablet every 6 to 8 hours, not to exceed 1 ½ tablets in 24 hours
children under 2 years of ageconsult a doctor
  • To prevent motion sickness, the first dose should be taken one half to one hour before starting activity.

    DO NOT EXCEED RECOMMENDED DOSE

Other information: store at room temperature, USP

  • Each tablet contains 29 mg of calcium

Inactive ingredients

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

*This product is not manufactured or distributed by Pfizer Consumer Healthcare owner of the registered trademark Dramamine® Tablets.

Manufactured by: CONTRACT PHARMACAL CORP.
135 Adams Ave., Hauppauge, NY 11788 USA / www.CPCHealth.com

02/08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DIMENHYDRINATE 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-1006
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (DIMENHYDRINATE) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code1006;1006
Contains    
Packaging
#Item CodePackage Description
1NDC:10267-1006-1100 TABLET (TABLET) in 1 BOTTLE
2NDC:10267-1006-41000 TABLET (TABLET) in 1 BOTTLE
3NDC:10267-1006-012 BLISTER PACK (BLISTER PACK) in 1 CASE
312 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33601/12/2001
Labeler - Contract Pharmacal Corp (968334974)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corp968334974MANUFACTURE

 
Contract Pharmacal Corp

← See all Dimenhydrinate brands

Medically reviewed on Nov 17, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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