DRAMAMINE- dimenhydrinate tablet, chewable

Dramamine by

Drug Labeling and Warnings

Dramamine by is a Otc medication manufactured, distributed, or labeled by Mechanical Servants, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• 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, 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 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

• Phenylketonurics: contains phenylalanine 0.84 mg per tablet.
• store at room temperature 68°-77°F (20°-25°C)
• do not use if packet is torn
• see bottom 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?

1-800-382-7219 Dramamine.com

SPL UNCLASSIFIED SECTION

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)

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)

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

INGREDIENTS AND APPEARANCE

DRAMAMINE 
dimenhydrinate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-1216
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM)	DIMENHYDRINATE	50 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	orange	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor	ORANGE	Imprint Code	DRA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29485-1216-2	2 in 1 BLISTER PACK	05/10/2010	12/31/2024
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M009	01/01/1994	12/31/2024

DRAMAMINE 
dimenhydrinate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-6925
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM)	DIMENHYDRINATE	50 mg

Inactive Ingredients
Ingredient Name	Strength
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)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	orange	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor	ORANGE	Imprint Code	DRA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29485-6925-3	3 in 1 BLISTER PACK	02/06/2017	12/31/2024
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M009	02/06/2017	12/31/2024

DRAMAMINE 
dimenhydrinate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-8048
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM)	DIMENHYDRINATE	50 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	orange	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor	ORANGE	Imprint Code	DRA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29485-8048-2	25 in 1 BOX	07/10/2020	12/31/2025
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M009	01/01/1994	12/31/2025

Labeler - Lil' Drug Store Products, Inc. (093103646)