MEDIQUE DIAMODE- 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:
Unifirst First Aid Corporation
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:
47682-200-33, 47682-200-46, 47682-200-50, 47682-200-64, 47682-200-69

MEDIQUE DIAMODE- loperamide hydrochloride tablet

Unifirst First Aid Corporation

----------

MEDIQUE

Diamode

Drug Facts

Active ingredient (in each caplet)

Loperamide HCl USP, 2mg

Purpose

Anti-diarrheal

Uses

Controls symptoms of diarrhea, including Travelers' Diarrhea.

Warnings

Allery 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

Ask a doctor before use if you have

a 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 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

Adults and children (12 years and over): Take 2 caplets after the first loose stool; 1 caplet after each

subsequent loose stool; but no more than 4 caplets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Other information

store between 68º - 77ºF (20º - 25ºC)

tamper-evident sealed packets

do not use any opened or torn packet

see back of packet for lot number and expiration date

Inactive ingredients

anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow # 10, FD&C Blue # 1,

hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Questions or comments?

1-800-634-7680

Medique Diamode Label

Collect MediBucks

See inside flap for more details

Medique

Diamode

Controls the Symptoms of Diarrhea

Controla los sintomas de la diarrea

Pull to Open

Tire

Para Abrir

This Package is for Households without Young Children

Este Paquete Es Para Hogares Sin Ninos Pequenos

Antidiarrheal Loperamide HCl 2 mg

Anti-diarreico Clorhidrato de loperamida 2 mg

100 Caplets

(100 x 1)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias

MEDIQUE DIAMODE

loperamide hydrochloride tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:476 8 2-20 0

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 (UNII: 6 8 40 19 6 0 MK)

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

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

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

PO WDERED CELLULO SE (UNII: SMD1X3XO9 M)

STARCH, CO RN (UNII: O8 232NY3SJ)

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

Product Characteristics

Color

green (Green)

S core

2 pieces

S hap e

OVAL (Caplet)

S iz e

10 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:476 8 2-20 0 -6 9

6 in 1 BOX

12/30 /20 0 8

Unifirst First Aid Corporation

1

1 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:476 8 2-20 0 -50

50 in 1 BOX

12/30 /20 0 8

2

1 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:476 8 2-20 0 -33

10 0 in 1 BOX

12/30 /20 0 8

3

1 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:476 8 2-20 0 -46

1 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

12/30 /20 0 8

5

NDC:476 8 2-20 0 -6 4

24 in 1 BOX

0 8 /14/20 20

5

1 in 1 PACKET; 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

ANDA

ANDA0 740 9 1

12/30 /20 0 8

Labeler -

Unifirst First Aid Corporation (832947092)

Revised: 7/2020

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