Medique ®

Medique ®
SPL v1
SPL
SPL Set ID ac674e5a-94df-4a35-9854-4e66cc17e509
Route
ORAL
Published
Effective Date 2025-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (2 mg)
Inactive Ingredients
Anhydrous Lactose Crospovidone D&c Yellow No. 10 Fd&c Blue No. 1 Magnesium Stearate Powdered Cellulose Starch, Corn Croscarmellose Sodium

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

Antidiarrheal


Medication Information

Purpose

Antidiarrheal

Description

Drug Facts

Uses

Controls the symptoms of diarrhea, including Travelers diarrhea.

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 53414-9

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

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.

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
Inactive Ingredients

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

Principal Display Panel

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.
Active Ingredient (in Each Caplet)

Loperamide Hydrochloride 2mg

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

Structured Label Content

Uses

Controls the symptoms of diarrhea, including Travelers diarrhea.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 53414-9 (53414-9)

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

Purpose

Antidiarrheal

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.

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
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

Principal Display Panel

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

Loperamide Hydrochloride 2mg

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)