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Motion Sickness Relief by CHAIN DRUG MARKETING ASSOCIATION INC

Medically reviewed on August 11, 2017

Dosage form: tablet
Ingredients: DIMENHYDRINATE 50mg
Labeler: CHAIN DRUG MARKETING ASSOCIATION INC
NDC Code: 63868-034

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.

Quality Choice 44-198

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic 

Uses

for the prevention and treatment of nausea, vomiting, or dizziness 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
  • difficulty in urination due to an 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
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery 

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 to under 12 years

1/2 to 1 tablet every 6-8 hours; do not exceed
3 tablets in 24 hours, or as directed by a
doctor
children 2 to under 6 years1/2 tablet every 6-8 hours; do not exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture 
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid 

Questions or comments?

1-800-426-9391 

Principal Display Panel

QC
QUALITY®
CHOICE

NDC 63868-034-24

Compare to the
Active Ingredient in
DRAMAMINE® ORIGINAL FORMULA

Motion Sickness Relief
Original Formula
Dimenhydrinate 50 mg / Antiemetic

Fast Acting Relief Of:
Motion Sickness for Children & Adults

Actual
Size

24 Tablets

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Original Formula.

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

100% QC
SATISFACTION
GUARANTEED

Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

50844    REV1115A19808
 

Quality Choice 44-198

MOTION SICKNESS RELIEF 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-034
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (DIPHENHYDRAMINE) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
SILICON DIOXIDE 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code44;198
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-034-244 BLISTER PACK in 1 CARTON
16 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33612/01/1992
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63868-034)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(63868-034)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(63868-034)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(63868-034)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(63868-034)

 
CHAIN DRUG MARKETING ASSOCIATION INC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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