Medique ® - DailyMed Details

Medique ®

SPL v5

SPL

SPL Set ID 9cf77219-c98d-487a-a5d3-61ceda6c65f5

Route

ORAL

Published

Effective Date 2025-10-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loperamide (2 mg)

Inactive Ingredients

Anhydrous Lactose Croscarmellose Sodium Crospovidone (120 .mu.m) D&c Yellow No. 10 Fd&c Blue No. 1 Magnesium Stearate Powdered Cellulose Starch, Corn Hydrogenated Cottonseed Oil

Identifiers & Packaging

Pill Appearance

Imprint: 123 Shape: oval Color: green Size: 10 mm Score: 2

Marketing Status

ANDA Active Since 2008-12-30

Description

Drug Facts

Purpose

Anti-diarrheal

Medication Information

Purpose

Anti-diarrheal

Description

Drug Facts

Uses

Controls symptoms of diarrhea, including Travelers' Diarrhea.

Section 42229-5

Drug Facts

Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

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.

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.

Do Not Use

•
if you have bloody or black stool

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

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

Questions Or Comments?

1-800-634-7680

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.

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).

Active Ingredient (in Each Caplet)

Loperamide HCl USP, 2mg

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

Structured Label Content

Uses

Controls symptoms of diarrhea, including Travelers' Diarrhea.

Section 42229-5 (42229-5)

Drug Facts

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Purpose

Anti-diarrheal

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.

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.

Do Not Use (Do not use)

•
if you have bloody or black stool

Other 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 Ingredients (Inactive ingredients)

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

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

Questions Or Comments? (Questions or comments?)

1-800-634-7680

When Using This Product (When using this product)

•
tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop Use and Ask A Doctor If (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.

Keep Out of Reach of Children. (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).

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Loperamide HCl USP, 2mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

•
taking antibiotics

Advanced Ingredient Data

[{"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE (120 .MU.M)", "unii": "68401960MK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POWDERED CELLULOSE", "unii": "SMD1X3XO9M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LOPERAMIDE", "unii": "6X9OC3H4II", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYDROGENATED COTTONSEED OIL", "unii": "Z82Y2C65EA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Controls symptoms of diarrhea, including Travelers' Diarrhea.", "42229-5": "Drug Facts", "53414-9": "If pregnant or breast feeding , ask a health professional before use.", "Purpose": "Anti-diarrheal", "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.", "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.", "Do not use": "• if you have bloody or black stool", "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", "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", "Questions or comments?": "1-800-634-7680", "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.", "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).", "Active ingredient (in each caplet)": "Loperamide HCl USP, 2mg", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:53.981757 · Updated: 2026-03-14T23:13:11.905913