MOTION SICKNESS- dimenhydrinate tablet
L&R Distributors, 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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Select Brand 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

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 to 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 to 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 to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º - 30ºC (59º - 86ºF)
protect from moisture
see end flap for expiration date and lot number

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 15127-262-12

select brand®
the lower price name brand

Motion Sickness Relief
Dimenhydrinate 50 mg
Antiemetic

Fast Acting Relief of Motion Sickness
for Children & Adults

*Compare to the Active Ingredient of Dramamine® Original Formula

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 Prestige Brands, Inc., owner of
the registered trademark Dramamine® Original
Formula. 50844 REV1115D19802

Distributed by:
SELECT BRAND® DISTRIBUTORS
Pine Bluff, AR 71603 USA
AC (870) 535-3635

Select Brand 44-198

MOTION SICKNESS
dimenhydrinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15127-262
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:15127-262-12	1 in 1 CARTON	12/01/1992	09/10/2021
1		12 in 1 BLISTER PACK; 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	09/10/2021

Labeler - L&R Distributors, Inc. (012578514)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(15127-262)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(15127-262)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(15127-262)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(15127-262)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(15127-262)

Revised: 4/2019

Document Id: ece862e9-ffb3-4582-b721-23d79fcefe54

Set id: 5be769d1-13a4-49f3-a6b5-bdd9ff3bdd1b

Version: 10

Effective Time: 20190406

L&R Distributors, Inc.