MOTION SICKNESS RELIEF- dimenhydrinate tablet
Better Living Brands, LLC

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.

----------

Signature Care 44-198-Delisted

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

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number
protect from moisture

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC 21130-198-12

Signature™
Care
Quality Guaranteed

COMPARE TO
Dramamine® Tablets
active ingredient*

Motion Sickness Relief
DIMENHYDRINATE 50 mg
Antiemetic

Fast acting relief of
motion sickness for
children & adults

Actual Size

100 TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Prestige Brands, Inc., distributors of Dramamine® Tablets.
50844 REV1013A19812

DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929
www.betterlivingbrandsLLC.com
SignatureCare 44-198

SignatureCare 44-198

MOTION SICKNESS RELIEF
dimenhydrinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21130-198
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M, CHLORTHEOPHYLLINE - UNII:GE2UA340FM)	DIMENHYDRINATE	50 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	44;198
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:21130-198-12	1 in 1 CARTON	12/01/1992	07/18/2019
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part336	12/01/1992	07/18/2019

Labeler - Better Living Brands, LLC (009137209)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(21130-198)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(21130-198)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(21130-198)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(21130-198)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(21130-198)

Revised: 7/2018

Document Id: 861617dd-7274-43c7-a69c-472280a463bc

Set id: d3e1e93c-96d2-40f6-8778-638fdbd9b531

Version: 7

Effective Time: 20180702

Better Living Brands, LLC