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NDC 71205-0316-01 MEDIQUE Diamode 2 mg/1 Details

MEDIQUE Diamode 2 mg/1

MEDIQUE Diamode is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is LOPERAMIDE HYDROCHLORIDE.

MedlinePlus Drug Summary

Nonprescription (over-the-counter) loperamide is used to control acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travelers' diarrhea. Prescription loperamide is also used to control acute diarrhea and also ongoing diarrhea associated with inflammatory bowel disease (IBD; condition in which the lining of all or part of the intestine is swollen, irritated, or has sores). Prescription loperamide is also used to reduce the amount of fluid in people with ileostomies (surgery to create an opening for waste to leave the body through the abdomen). Loperamide is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel and by slowing down the movement of the bowel to decrease the number of bowel movements.

Related Packages: 71205-0316-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loperamide

Product Information

NDC	71205-0316
Product ID	71205-316_d327994a-8748-4c6c-b1c9-21401060bbce
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	MEDIQUE Diamode
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loperamide Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	2
Active Ingredient Units	mg/1
Substance Name	LOPERAMIDE HYDROCHLORIDE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA074091
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71205-0316-01 (71205031601)

Pricing Information	N/A
NDC Package Code	71205-316-01
Billing NDC	71205031601
Package	1 TABLET in 1 PACKET (71205-316-01)
Marketing Start Date	2019-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9cf77219-c98d-487a-a5d3-61ceda6c65f5 Details

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

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
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074091	12/30/2008

Labeler - Proficient Rx LP (079196022)

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

Revised: 1/2021

Document Id: d327994a-8748-4c6c-b1c9-21401060bbce

Set id: 9cf77219-c98d-487a-a5d3-61ceda6c65f5

Version: 3

Effective Time: 20210101