MOTION SICKNESS- dimenhydrinate tablet 
Harmon Store 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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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

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

Core Values 44-198

Core Values 44-198

MOTION SICKNESS 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-198
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M, CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code 44;198
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-198-021 in 1 PACKAGE12/01/199202/22/2019
112 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33612/01/199202/22/2019
Labeler - Harmon Store Inc. (804085293)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(63940-198)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(63940-198)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(63940-198)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(63940-198)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(63940-198)

Revised: 8/2020
 
Harmon Store Inc.