LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride tablet

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

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Active ingredient:
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)
Available from:
Fred's Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-diarrheal controls symptoms of diarrhea, including Travelers' Diarrhea
Authorization status:
Abbreviated New Drug Application
Authorization number:
55315-123-06, 55315-123-24

LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride tablet

Fred's Inc.

----------

Loperamide Hydrochloride

Drug Facts

Active ingredient (in each caplet)

Loperamide Hydrochloride USP, 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 hydrochloride

Heart alert

Taking more than directed can cause serious heart problems or death

Do not use if you have bloody or black stool

Ask a doctor before use if you have

fever

mucus in the stool

a history of liver disease

a history of abnormal heart rhythm

Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact

with certain prescription drugs.

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 (1-800-222-1222).

Directions

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

find right dose on chart. If possible, use weight to dose; otherwise, use age.

adults and children 12 years

and over

2 caplets after the first loose

stool; 1 caplet after each

subsequent loose stool; but no

more than 4 caplets in 24 hours

children 9-11 years

(60-95 lbs)

1 caplet after the first loose

stool; ½ caplet after each

subsequent loose stool; but no

more than 3 caplets in 24 hours

children 6-8 years

(48-59 lbs)

1 caplet after the first loose

stool; ½ caplet after each

subsequent loose stool; but no

more than 2 caplets in 24 hours

children 2-5 years

(34 to 47 lbs)

ask a doctor

children under 2 years

(up to 33 lbs)

do not use

Other information

store between 20° – 25°C (68° – 77°F)

see side panel for lot number and expiration date

TAMPER EVIDENT: THIS PRODUCT IS PROTECTED WITH SEALED BLISTER

UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Inactive ingredients

anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C

blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose,

pregelatinized starch

Ques tions ?

Call toll-free Monday-Friday 8:30 am to 5 pm EST at 1 800-406-7984.

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL RD,

MEMPHIS, TN 38118

PRINCIPAL DISPLAY PANEL - 2 mg Caplet Blister Pack Carton

fred's

See New Warnings

and Directions

Shown at

Actual Size

Loperamide Hydrochloride

Tablets USP, 2 mg

Anti-Diarrheal

Controls The Symptoms of Diarrhea

6 CAPLETS*

Each caplet (*capsule-shaped tablet) contains

Loperamide Hydrochloride USP, 2 mg

fred's

LAB TESTED®

Lab Tested for Quality,

Fred Tested for Satisfaction

Compare To

Active Ingredient of

Imodium A-D

LOPERAMIDE HYDROCHLORIDE

loperamide hydrochloride tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55315-123

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LO PERAMIDE HYDRO CHLO RIDE (UNII: 77TI3539 3C) (LOPERAMIDE -

UNII:6 X9 O C3H4II)

LOPERAMIDE

HYDROCHLORIDE

2 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

CRO SPO VIDO NE ( 15 MPA.S AT 5%) (UNII: 6 8 40 19 6 0 MK)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

HYDRO GENATED CO TTO NSEED O IL (UNII: Z8 2Y2C6 5EA)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

PO WDERED CELLULO SE (UNII: SMD1X3XO9 M)

STARCH, CO RN (UNII: O8 232NY3SJ)

Product Characteristics

Color

gre e n

S core

2 pieces

S hap e

CAPSULE

S iz e

9 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55315-123-0 6

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

0 2/0 1/19 9 3

2

NDC:55315-123-24

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

0 2/0 1/19 9 3

Fred's Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 740 9 1

0 2/0 1/19 9 3

Labeler -

Fred's Inc. (005866116)

Registrant -

Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ohm Labo rato ries Inc.

0 5156 5745

ma nufa c ture (55315-123)

Revised: 5/2019

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