Dramamine® Chewable Formula

Drug Labeling and Warnings

Drug Details [pdf]

DRAMAMINE- dimenhydrinate tablet, chewable 
Lil' Drug Store Products, 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® 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 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 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 1-½ 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 pouch is opened.
• 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 or comments ?

Call 1-800-382-7219

Repackaged and distributed by:
Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402

PRINCIPAL DISPLAY PANEL - 2 Tablet Carton

#1
Pharmacist
Recommended
Brand

Dimenhydrinate
Tablets/Antiemetic

CHEWABLE FORMULA
Dramamine®

MOTION SICKNESS RELIEF

DUAL ACTION

1. TREATS SYMPTOMS
   ON THE SPOT
2. PREVENTS NAUSEA,
   DIZZINESS & VOMITING

Convenient
Chewable Tablets

2 ORANGE FLAVORED
TABLETS (50 mg EACH)

2 TABLETS

Lil'
Drug Store ®

DRAMAMINE 
dimenhydrinate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-9709
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimenhydrinate (UNII: JB937PER5C) (Diphenhydramine - UNII:8GTS82S83M)	Dimenhydrinate	50 mg

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
aspartame (UNII: Z0H242BBR1)
FD&C yellow no. 6 (UNII: H77VEI93A8)
aluminum oxide (UNII: LMI26O6933)
magnesium stearate (UNII: 70097M6I30)
maltodextrin (UNII: 7CVR7L4A2D)
sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	ORANGE	Score	2 pieces
Shape	ROUND (Circular Flat Faced Tablet)	Size	12mm
Flavor	ORANGE	Imprint Code	DRAMAMINE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-9709-1	1 in 1 CARTON	05/10/2010	08/26/2019
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 FINAL	part336	05/10/2010	08/26/2019

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

Revised: 7/2018

Document Id: 3723c1e7-92c6-40bd-a81c-c65ee8caa01c

34390-5

Set id: 09936316-8667-4950-b017-19e3a05385a4

Version: 4

Effective Time: 20180712

 

Lil' Drug Store Products, Inc.