Freds Pharmacy 44-198

Freds Pharmacy 44-198

Drug Labeling and Warnings

Drug Details

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MOTION SICKNESS RELIEF- dimenhydrinate tablet 
FRED'S, 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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Freds Pharmacy 44-198

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

  • 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
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

  • each tablet contains: calcium 35 mg
  • see end flap for expiration date and lot number
  • 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

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal display panel

fred's
Pharmacy

NDC: 55315-198-02

*Compare to active ingredient in
Dramamine® Original Formula

ORIGINAL FORMULA
Motion Sickness Relief
Dimenhydrinate 50 mg Antiemetic 

Prevents Nausea, Vomiting
& Dizziness for Children & Adults

12 TABLETS

Actual Size

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

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

50844 ORG051819802

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD., MEMPHIS, TN 38118
www.fredsinc.com

100%
satisfaction
guaranteed

Questions or comments:
1-855-331-FRED(3733)

Freds Pharmacy 44-198

Freds Pharmacy 44-198

MOTION SICKNESS RELIEF 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55315-198
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)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize9mm
FlavorImprint Code 44;198
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55315-198-022 in 1 CARTON05/01/2019
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33605/01/2019
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(55315-198)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(55315-198)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(55315-198)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(55315-198)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(55315-198)

Revised: 3/2019
 
FRED'S, INC.


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