LIL DRUG STORE ANTI-DIARRHEAL SOFT GELATIN- loperamide hydrochloride capsule, liquid filled

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Loperamide Hydrochloride (UNII: 77TI35393C) (Loperamide - UNII:6X9OC3H4II)
Available from:
Lil' Drug Store Products, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-diarrheal Controls symptoms of diarrhea, including Travelers' Diarrhea.
Authorization status:
New Drug Application
Authorization number:
66715-6859-0

LIL DRUG STORE ANTI-DIARRHEAL SOFT GELATIN- loperamide hydrochloride capsule,

liquid filled

Lil' Drug Store Products, Inc.

----------

Lil' Drug Store

Anti-Diarrheal

Soft Gelatin Capsules

Drug Facts

Active ingredient (in each capsule)

Loperamide HCl, 2 mg

Purpos e

Anti-diarrheal

Us e

Controls symptoms of diarrhea, including Travelers' Diarrhea.

Warnings

Allergy alert

Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.

Heart alert

Taking more than directed can cause serious heart problems or death.

Do not use

if you have bloody or black stool

in children under 12 years of age

Ask a doctor before use if you have

fever

mucus in the stool

a history of liver disease

Ask a doctor or pharmacist before use if you are taking antibiotics.

When using this product tiredness, drowsiness, or dizziness may occur. Be careful when driving or

operating machinery.

Stop use and ask a doctor if

symptoms get worse

diarrhea lasts for more than 2 days

you get abdominal swelling or bulging.

These may be signs of a serious condition.

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 right away.

Directions

drink plenty of clear fluids to help prevent dehydration caused by diarrhea

not for use in children under 12 years of age

adults and children 12 years of age and over: 2 softgels after the first loose stool; 1 softgel after

each subsequent loose stool; but no more than 4 softgels in 24 hours

Other information

store at 20°-25°C (68°-77°F). Protect from light.

avoid excessive heat above 40°C (104°F)

do not use if carton or blister unit is open or torn

see side panel for lot number and expiration date

Inactive ingredients

butylated hydroxyanisole, edible ink, FD&C blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40

hydrogenated castor oil, purified water

Questions or comments?

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Product distributed by:

Lil' Drug Store Products, Inc.

1201 Continental Place NE

Cedar Rapids, IA 52402

PRINCIPAL DISPLAY PANEL - 2 mg Capsule Blister Pack Carton

QUALITY

GUARANTEED

Compare to the Active

Ingredient in Imodium® A-D*

Anti-Diarrheal

Loperamide HCl, 2 mg

Soft Gelatin Capsules

Controls the Symptoms of Diarrhea

ACTUAL SIZE

12

Softgels **

Lil'

Drug Store

®

LIL DRUG STORE ANTI-DIARRHEAL SOFT GELATIN

loperamide hydrochloride capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 6 715-6 8 59

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Lo pera mide Hydro chlo ride (UNII: 77TI3539 3C) (Lo peramide - UNII:6 X9 OC3H4II)

Lo peramide Hydro chlo ride

2 mg

Inactive Ingredients

Ingredient Name

Stre ng th

Butyla ted Hydro xya niso le (UNII: REK49 6 0 K2U)

FD&C Blue No . 1 (UNII: H3R47K3TBD)

Gela tin, unspecified (UNII: 2G8 6 QN327L)

Glycerin (UNII: PDC6 A3C0 OX)

Glyceryl Mo no ca pryla te (UNII: TM2TZD4G4A)

Po lyo xyl 4 0 Hydro g ena ted Ca sto r O il (UNII: 7YC6 8 6 GQ8 F)

Wa ter (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

BLUE

S core

no sco re

S hap e

CAPSULE

S iz e

10 mm

Flavor

Imprint Code

Contains

Lil' Drug Store Products, Inc.

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:6 6 715-6 8 59 -0

1 in 1 CARTON

0 2/0 1/20 15

0 2/27/20 22

1

12 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 218 55

0 2/0 1/20 15

0 2/27/20 22

Labeler -

Lil' Drug Store Products, Inc. (093103646)

Revised: 3/2019

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