DRAMAMINE- dimenhydrinate tablet 
Navajo Manufacturing Company Inc.

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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Dramamine

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 doctor before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity
to prevent or treat motion sickness:

 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 1/2 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 1/2 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 at room temperature 20º-25ºC (68º- 77ºF)

• do not use if pouch is opened

• see pouch 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

Package Labeling:

Dramamaine

DRAMAMINE 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-170(NDC:63029-901)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColororangeScore2 pieces
ShapeROUNDSize8mm
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67751-170-011 in 1 CARTON09/23/2016
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:67751-170-021 in 1 CARTON09/23/2016
24 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33609/23/2016
Labeler - Navajo Manufacturing Company Inc. (091917799)
Establishment
NameAddressID/FEIBusiness Operations
Navajo Manufacturing Company Inc.136941411relabel(67751-170) , repack(67751-170)

Revised: 3/2023
Document Id: f6f79a87-6831-c39d-e053-6394a90ae629
Set id: 4139b5bf-2e49-40c3-9f4a-d8e15c044ead
Version: 3
Effective Time: 20230315
 
Navajo Manufacturing Company Inc.