MEDIQUE DIAMODE- loperamide hydrochloride tablet

MEDIQUE Diamode by

Drug Labeling and Warnings

MEDIQUE Diamode by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. 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

Diamode

Controls the Symptoms of Diarrhea

Pull to Open

See New Warnings Information

Antidiarrheal Loperamide HCl 2 mg

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

MEDIQUE DIAMODE 
loperamide hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71205-316(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 (15 MPA.S AT 5%) (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: 71205-316-01	1 in 1 PACKET; Type 0: Not a Combination Product	09/01/2019
2	NDC: 71205-316-06	6 in 1 PACKET; Type 0: Not a Combination Product	10/01/2019

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

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(71205-316) , RELABEL(71205-316)