MOTION SICKNESS- dimenhydrinate tablet 
Freds 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.

----------

Drug Facts

Active Ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Uses

for prevention and treatment of these symptoms associated with motion sickness:

Warnings
Do not use

in children under 2 years of age, unless directed by a doctor

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and over take 1 to 2 tablets every 4 to 6 hours; not to exceed 8 tablets in 24 hours or as directed by a doctor
 children 6 to under 12 years of age take 1/2 to 1 tablet every 6 to 8 hours; not to exceed 3 tablets in 24 hours or as directed by a doctor
 children 2 to under 6 years of age take 1/4 to 1/2 tablet every 6 to 8 hours; not to exceed 1- 1/2 tablets in 24 hours or as directed by a doctor.

Other information

Inactive ingredients

Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate and Microcrystalline Cellulose.

Questions or comments?

Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

PRINCIPAL DISPLAY PANEL

Compare to Active Ingredient in Dramamine®*

Motion Sickness

Dimenhydrinate Tablets/ Antiemetic

Fast acting motion sickness relief

For children and Adults

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Freds Inc

Dimenhydrinate 50 mg

MOTION SICKNESS 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-630
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (DIPHENHYDRAMINE) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code 1006;1006
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-630-121 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33607/08/2010
Labeler - Freds Inc (005866116)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 01/2013
Document Id: 1f1128f4-990b-49ce-99a4-73eac2f7a7b0
Set id: ac5b8b25-8687-4d59-8726-bba9ab5339c3
Version: 1
Effective Time: 20130109
 
Freds Inc