Handy Solutions Anti-diarrheal

SPL v3

SPL

SPL Set ID 76e32e66-4af5-47a5-83ff-cbba206975d6

Route

ORAL

Published

Effective Date 2016-09-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loperamide (2 mg)

Inactive Ingredients

Anhydrous Lactose Croscarmellose Sodium Crospovidone D&c Yellow No. 10 Fd&c Blue No. 1 Magnesium Stearate Powdered Cellulose

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2016-09-21

Description

Loperamide Hydrochloride 2 mg

Purpose

Antidiarrheal

Medication Information

Purpose

Antidiarrheal

Description

Loperamide Hydrochloride 2 mg

Uses

Controls the symptoms of diarrhea, including Traveler’s diarrhea

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.

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 bowel movement followed by 1 caplet after each subsequent loose bowel movement 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 stools

Other Information

• store between 68º - 77ºF (20º - 25ºC)

• tamper-evident sealed packets

• do not use any opened or torn packet

Package Labeling:

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?

1-800-525-5097

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 2 mg

Ask A Doctor Before Use If You Have

• a fever

• mucus in stool

• a history of liver disease

If You Are Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Or Pharmacist Before Use If You Are

• taking antibiotics

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.

Structured Label Content

Uses

Controls the symptoms of diarrhea, including Traveler’s diarrhea

Purpose

Antidiarrheal

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.

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 bowel movement followed by 1 caplet after each subsequent loose bowel movement 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 stools

Other Information (Other information)

• store between 68º - 77ºF (20º - 25ºC)

• tamper-evident sealed packets

• do not use any opened or torn packet

Package Labeling:

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

Questions Or Comments? (Questions or comments?)

1-800-525-5097

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 2 mg

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

If You Are Pregnant Or Breast Feeding, (If you are pregnant or breast feeding,)

ask a health professional before use.

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

• taking antibiotics

Keep This and All Drugs Out of the Reach of Children. (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.

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", "unii": "2S7830E561", "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": "LOPERAMIDE", "unii": "6X9OC3H4II", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Controls the symptoms of diarrhea, including Traveler’s diarrhea", "Purpose": "Antidiarrheal", "Warnings": "Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.", "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 bowel movement followed by 1 caplet after each subsequent loose bowel movement 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 stools", "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?": "1-800-525-5097", "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 2 mg", "Ask a doctor before use if you have": "• a fever • mucus in stool • a history of liver disease", "If you are pregnant or breast feeding,": "ask a health professional before use.", "Ask a doctor or pharmacist before use if you are": "• taking antibiotics", "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."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:36.997817 · Updated: 2026-03-14T23:01:06.342894