Medique Diamode (Loperamide Hydrochloride) Tablet [Unifirst First Aid Corporation] -

MEDIQUE DIAMODE (LOPERAMIDE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]
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NDC	47682-200-33, 47682-200-46, 47682-200-50, 47682-200-69
Set ID	069e7979-a223-4819-b6cf-ea2731bf156b
Category	HUMAN OTC DRUG LABEL
Packager	Unifirst First Aid Corporation
Generic Name
Product Class
Product Number
Application Number	ANDA074091

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredient (in each caplet)

Loperamide HCl USP, 2mg
PURPOSE

Purpose

Anti-diarrheal
INDICATIONS & USAGE

Uses

Controls symptoms of diarrhea, including Travelers' Diarrhea.
WARNINGS
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
- a history of abnormal heart rythm
Ask a doctor or pharmacist before use if you are
- taking a precription drug. Loperamide may interect 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 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 the 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: ask a doctor
OTHER SAFETY INFORMATION
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 INGREDIENT

Inactive ingredients

anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow # 10 aluminum lake, FD&C Blue # 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch
QUESTIONS

Questions or comments?

1-800-634-7680
Medique Diamode Label

Medique ®

Diamode

Controls the Symptoms of Diarrhea

Pull to Open

This Package is for Households without Young Children.

Antidiarrheal • Loperamide HCl 2 mg

24 Caplets

(24 x 1)

Tamper Evident Unit Dose Packets

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

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

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
STARCH, CORN (UNII: O8232NY3SJ)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 68401960MK)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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	05/01/2023
2		1 in 1 PACKET; Type 0: Not a Combination Product
3	NDC:47682-200-33	100 in 1 BOX	12/30/2008	05/01/2023
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
5	NDC:47682-200-64	24 in 1 BOX	08/14/2020
5		1 in 1 PACKET; Type 0: Not a Combination Product