MOTION SICKNESS RELIEF- dimenhydrinate tablet

Motion Sickness Relief by

Drug Labeling and Warnings

Motion Sickness Relief by is a Otc medication manufactured, distributed, or labeled by Topco Associates, LLC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Uses

for the 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
  
• difficulty in urination due to enlargement of the prostate gland
  

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• marked drowsiness may occur
  
• alcohol, sedatives, and tranquilizers may increase drowsiness
  
• use caution when driving a motor vehicle or operating machinery
• avoid alcoholic beverages
  

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 (1-800-222-1222) right away.

Directions

• to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity

• adults and children 12 years and over: 1 to 2 tablets every 4-6 hours; do not exceed 8 tablets in 24 hours, or as directed by a doctor
• children 6 tounder 12 years: ½ to 1 tablet every 6-8 hours; do not exceed 3 tablets in 24 hours, or as directed by a doctor
• children 2 tounder 6 years: ½ tablet every 6-8 hours; do not; exceed 1½ tablets in 24 hours, or as directed by a doctor

Other information

• each tablet contains: calcium 35 mg
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• protect from moisture
  
• see end flap for expiration date and lot number
  

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or comments?

1-888-423-0139

Principal display panel

TopCare®
        health™

NDC: 36800-930-12

COMPARE TO DRAMAMINE® ORIGINAL
FORMULA ACTIVE INGREDIENT*

ORIGINAL FORMULA

Motion Sickness Relief

DIMENHYDRINATE, 50 mg - ANTIEMETIC

Prevents Nausea, Dizziness & Vomiting

12 TABLETS

For Children & Adults

actual size

*This product is not manufactured or distributed by Medtech
Product Inc., owner of the registered trademark Dramamine®
Original Formula. 50844     REV0518A19802

DISTRIBUTED BY TOPCO ASSOCIATES LLC,
ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA1018 QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com

This TopCare® product is laboratory
tested to guarantee its highest quality.
Your total satisfaction is guaranteed

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING

Topcare 44-198

INGREDIENTS AND APPEARANCE

MOTION SICKNESS RELIEF 
dimenhydrinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-930
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M, CHLORTHEOPHYLLINE - UNII:GE2UA340FM)	DIMENHYDRINATE	50 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	44;198
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-930-12	2 in 1 CARTON	12/01/1992
1		6 in 1 BLISTER PACK; 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	12/01/1992

Labeler - Topco Associates, LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(36800-930)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(36800-930)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(36800-930)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(36800-930)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(36800-930)