Dramamine Chewable Formula

Dosage form: tablet, chewable
Ingredients: Dimenhydrinate 50mg
Labeler: McNeil Consumer Healthcare Div McNeil-PPC, Inc
NDC Code: 50580-310

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.

Dramamine®
CHEWABLE FORMULA

Drug Facts

Active ingredient (in each tablet)

Dimenhydrinate 50 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 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
  • 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
  • marked 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 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. (1-800-222-1222)

Directions
  • to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
  • to prevent or treat motion sickness, see below:
adults and children 12 years and over
  • take 1 to 2 chewable tablets every 4-6 hours
  • do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years
  • give ½ to 1 chewable tablet every 6-8 hours
  • do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years
  • give ½ chewable tablet every 6-8 hours
  • do not give more than 1-1/2 chewable tablets in 24 hours, or as directed by a doctor

Other information
  • Phenylketonurics: contains phenylalanine 0.84 mg per tablet
  • store between 20–25°C (68–77°F)
  • do not use if carton is opened or if blister unit is broken or torn
  • see side panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, aspartame, FD&C yellow #6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol

Questions or comments?

call 1-800-382-7219

PRINCIPAL DISPLAY PANEL

NDC 50580-310-08

Dimenhydrinate Tablets/Antiemetic
Dramamine®
CHEWABLE FORMULA

Convenient Chewable Tablets
For Children and Adults.

8 ORANGE FLAVOR TABLETS (50 mg EACH)

DRAMAMINE   CHEWABLE FORMULA
dimenhydrinate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-310
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimenhydrinate (Dimenhydrinate) Dimenhydrinate50 mg
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
aspartame 
FD&C yellow no. 6 
aluminum oxide 
magnesium stearate 
maltodextrin 
sorbitol 
Product Characteristics
ColorORANGEScore2 pieces
ShapeROUND (Circular Flat Faced Tablet) Size12mm
FlavorORANGEImprint CodeDRAMAMINE
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-310-022 TABLET, CHEWABLE in 1 POUCH
2NDC:50580-310-081 BLISTER PACK in 1 CARTON
28 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33610/01/200808/31/2013
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 04/2012
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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