MEDIQUE DIAMODE- loperamide hydrochloride tablet

MEDIQUE Diamode by

Drug Labeling and Warnings

MEDIQUE Diamode by is a Otc medication manufactured, distributed, or labeled by Sportpharm, Inc. dba Sportpharm, ASCLEMED USA INC. DBA ENOVACHEM. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

Loperamide Hydrochloride 2mg

Purpose

Antidiarrheal

Uses

Controls the 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

Do not use

• if you have bloody or black stool

Ask a doctor before use if you have

• a fever
• mucus in 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 you are pregnant or breast feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a physician or Poison Control Center right away.

Directions

• do not use more than directed
• drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Adults and children (12 years and older):Take 2 caplets after the first loose stool followed by 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

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

MEDIQUE DIAMODE 
loperamide hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85766-120(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)
CROSPOVIDONE (UNII: 2S7830E561)
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)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

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: 85766-120-06	6 in 1 BOX, UNIT-DOSE	12/12/2025
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 85766-120-01	1 in 1 PACKET; Type 0: Not a Combination Product	12/12/2025
3	NDC: 85766-120-24	24 in 1 BOX, UNIT-DOSE	12/12/2025
3	NDC: 85766-120-01	1 in 1 PACKET; Type 0: Not a Combination Product

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

Labeler - Sportpharm, Inc. dba Sportpharm (139010449)

Establishment
Name	Address	ID/FEI	Business Operations
ASCLEMED USA INC. DBA ENOVACHEM		059888437	relabel(85766-120)