DRAMAMINE- dimenhydrinate tablet, chewable 
Mechanical Servants, LLC

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

DRUG FACTS

Drug Facts

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Use

for prevention and treatment of these symptoms 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
  • 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

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 that 1 1/2 chewable tablets in 24 hours, or as directed by a doctor

Other Information

Inactive ingredients

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

Questions?

1-800-382-7219 Dramamine.com

Dist. by Medtech Products Inc., Tarrytown, NY 10591
A Prestige Consumer Healthcare company. Made in Italy.
© 2021 Trade dress is owned by Medtech Products Inc.
All rights reserved.

PRINCIPAL DISPLAY PANEL - 50mg Tablet Pouch Blister

#1
Pharmacist
Recommended
Brand

Dimenhydrinate
Tablets/Antiemetic

Dramamine ®


motion sickness

CHEWABLE
Dual Action:

Prevents & Relieves Nausea,

Dizziness and Vomiting


4

Orange Flavored

Tablets (50 mg each)

PDP

PRINCIPAL DISPLAY PANEL - 50mg Tablet Pouch Blister

#1
Pharmacist
Recommended
Brand

Dimenhydrinate
Tablets/Antiemetic

Dramamine ®


motion sickness

CHEWABLE
Dual Action:

Prevents & Relieves Nausea,

Dizziness and Vomiting


6

Orange Flavored Tablets (50 mg each)

DRAMAMINE 6CT

PRINCIPAL DISPLAY PANEL - 50mg Tablet Pouch Box

#1
Pharmacist
Recommended
Brand

Dimenhydrinate
Tablets/Antiemetic

Dramamine ®


motion sickness

CHEWABLE
Dual Action:

Prevents & Relieves Nausea,

Dizziness and Vomiting


25 POUCHES

2 Orange Flavored Tablets (50 mg each) per Pouch

PDP

DRAMAMINE 
dimenhydrinate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-6925
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
SORBITOL (UNII: 506T60A25R)  
ASPARTAME (UNII: Z0H242BBR1)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColororangeScore2 pieces
ShapeROUNDSize12mm
FlavorORANGEImprint Code DRA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-6925-33 in 1 BLISTER PACK02/06/2017
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33602/06/2017
DRAMAMINE 
dimenhydrinate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-1216
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
SORBITOL (UNII: 506T60A25R)  
ASPARTAME (UNII: Z0H242BBR1)  
STARCH, CORN (UNII: O8232NY3SJ)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColororangeScore2 pieces
ShapeROUNDSize12mm
FlavorORANGEImprint Code DRA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-1216-22 in 1 BLISTER PACK05/10/2010
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33601/01/1994
DRAMAMINE 
dimenhydrinate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-8048
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
SORBITOL (UNII: 506T60A25R)  
ASPARTAME (UNII: Z0H242BBR1)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColororangeScore2 pieces
ShapeROUNDSize12mm
FlavorORANGEImprint Code DRA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-8048-225 in 1 BOX07/10/2020
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33601/01/1994
Labeler - Mechanical Servants, LLC (005530951)

Revised: 8/2022
Document Id: e65f82eb-3ad3-1d24-e053-2995a90adf87
Set id: cee22d00-e8a1-d735-e053-2995a90aec04
Version: 6
Effective Time: 20220816
 
Mechanical Servants, LLC