Motion Sickness Relief: Package Insert and Label Information

MOTION SICKNESS RELIEF- dimenhydrinate tablet
CHAIN DRUG MARKETING ASSOCIATION 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.

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Uses

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
  • 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

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • marked drowsiness may occur
  • 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 to under12 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 to under6 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?

1-800-426-9391

Principal Display Panel

NDC 63868-034-12

QC®
QUALITY
CHOICE

Compare to the
Active Ingredient in
DRAMAMINE® ORIGINAL FORMULA*

Motion Sickness Relief
Original Formula
Dimenhydrinate 50 mg | Antiemetic

Prevents: Nausea, Vomiting & Dizziness
for Children & Adults

actual
size

24 Tablets

*This product is not manufactured or distributed by
Medtech Products Inc., owner of the registered trademark
Dramamine® Original Formula.
50844 REV0518B19808

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 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 248-449-9300

Quality Choice 44-198
(click image for full-size original)

Quality Choice 44-198

MOTION SICKNESS RELIEF dimenhydrinate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-034
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMENHYDRINATE (DIPHENHYDRAMINE and CHLORTHEOPHYLLINE) DIMENHYDRINATE 50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STEARIC ACID
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code 44;198
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63868-034-24 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 6 TABLET in 1 BLISTER PACK This package is contained within the CARTON (63868-034-24)
2 NDC:63868-034-12 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 6 TABLET in 1 BLISTER PACK This package is contained within the CARTON (63868-034-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part336 12/01/1992
Labeler — CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (63868-034)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (63868-034)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 pack (63868-034)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 pack (63868-034)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (63868-034)

Revised: 09/2021 CHAIN DRUG MARKETING ASSOCIATION INC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.