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Motion Sickness by Harmon Store Inc.

Medically reviewed on August 29, 2017

Dosage form: tablet
Ingredients: DIMENHYDRINATE 50mg
Labeler: Harmon Store Inc.
NDC Code: 63940-198

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.

Core Values 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 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
under 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 to
under 6 years
½ tablet every 6-8 hours;
do not exceed 1½ tablets in 24
hours, or as directed by a doctor

Other information
  • protect from moisture
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive ingredients

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

Questions or comments? 1-800-426-9391

Principal Display Panel

CORE VALUES™

Compare to active ingredient in
Dramamine® Original Formula

NDC 63940-198-02

Motion Sickness
Dimenhydrinate 50 mg   Antiemetic
Fast Acting Relief of Motion Sickness

Actual Size

12 tablets

TAMPER EVIDENT: Use Only if This Blister is Intact

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

50844    REV1115A19802

Satisfaction Guaranteed
Or Your Money Back
Visit us at www.facevalues.com

Distributed by:
Liberty Procurement, Inc., 650 Liberty Ave., Union, NJ 07083 U.S.A.

Core Values 44-198

MOTION SICKNESS 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-198
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (DIPHENHYDRAMINE and CHLORTHEOPHYLLINE) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
STEARIC ACID 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
SILICON DIOXIDE 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code44;198
Contains    
Packaging
#Item CodePackage Description
1NDC:63940-198-021 BOTTLE in 1 PACKAGE
112 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33612/01/1992
Labeler - Harmon Store Inc. (804085293)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63940-198)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(63940-198)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(63940-198)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(63940-198)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(63940-198)

 
Harmon Store Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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