MEDIQUE DIAMODE- loperamide hydrochloride tablet

MEDIQUE Diamode by

Drug Labeling and Warnings

MEDIQUE Diamode by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

MEDIQUE DIAMODE 
loperamide hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-200
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 68401960MK)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
STARCH, CORN (UNII: O8232NY3SJ)
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)

Product Characteristics
Color	green (Green)	Score	2 pieces
Shape	OVAL (Caplet)	Size	10mm
Flavor		Imprint Code	123
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-200-69	6 in 1 BOX	12/30/2008
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-200-50	50 in 1 BOX	12/30/2008
2		1 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-200-33	100 in 1 BOX	12/30/2008
3		1 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 47682-200-46	1 in 1 PACKET; Type 0: Not a Combination Product	12/30/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074091	12/30/2008

Labeler - Unifirst First Aid Corporation (832947092)