welmate anti-diarrheal (loperamide hcl) softgels

SPL v3

SPL

SPL Set ID ae2e15e9-1707-296d-e053-2995a90a1b95

Route

oral

Published

Effective Date 2020-08-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

loperamide (2 mg)

Inactive Ingredients

butylated hydroxyanisole fd&c blue no. 1 gelatin glycerin glyceryl caprylate polyoxyl 40 hydrogenated castor oil water

Identifiers & Packaging

Pill Appearance

Imprint: LP2 Shape: oval Color: blue Size: 9 mm Score: 1

Marketing Status

nda active Since 2020-08-22

Purpose

Anti-diarrheal

Description

Loperamide HCl 2 mg

Medication Information

Warnings

Allergy 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.

Purpose

Anti-diarrheal

Directions

drink plenty of clear fluids to help prevent dehydration caused by diarrhea
not for use in children under 12 years of age
adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other Information

do not use if blister unit is torn or open
store at 20°- 25°C (68° - 77°F)

Inactive Ingredients

butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water.

Description

Loperamide HCl 2 mg

Questions?

call toll-free 1-800-935-6737

Use

Controls symptoms of diarrhea, including Travelers’ Diarrhea

Do Not Use:

if you have bloody or black stool
in children under 12 years of age

Package Labeling:

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 (1-800-222-1222) right away.

Active Ingredient (in Each softgel)

Loperamide HCl 2 mg

Ask A Doctor Before Use If You Have:

fever
mucus in the stool
a history of liver disease
a history of abnormal heart rhythm
Ask a doctor before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

Structured Label Content

Warnings

Allergy 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.

Purpose

Anti-diarrheal

Directions

drink plenty of clear fluids to help prevent dehydration caused by diarrhea
not for use in children under 12 years of age
adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other Information (Other information)

do not use if blister unit is torn or open
store at 20°- 25°C (68° - 77°F)

Inactive Ingredients (Inactive ingredients)

butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water.

Questions?

call toll-free 1-800-935-6737

Use

Controls symptoms of diarrhea, including Travelers’ Diarrhea

Do Not Use: (Do not use:)

if you have bloody or black stool
in children under 12 years of age

Package Labeling:

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 (1-800-222-1222) right away.

Active Ingredient (in Each softgel) (Active ingredient (in each softgel))

Loperamide HCl 2 mg

Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)

fever
mucus in the stool
a history of liver disease
a history of abnormal heart rhythm
Ask a doctor before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

Advanced Ingredient Data

[{"name": "BUTYLATED HYDROXYANISOLE", "unii": "REK4960K2U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL CAPRYLATE", "unii": "TM2TZD4G4A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "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)

{"Use": "Controls symptoms of diarrhea, including Travelers’ Diarrhea", "Purpose": "Anti-diarrheal", "Warnings": "Allergy 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 not for use in children under 12 years of age adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours", "Questions?": "call toll-free 1-800-935-6737", "Do not use:": "if you have bloody or black stool in children under 12 years of age", "Other information": "do not use if blister unit is torn or open store at 20°- 25°C (68° - 77°F)", "Inactive ingredients": "butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water.", "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 (1-800-222-1222) right away.", "Active ingredient (in each softgel)": "Loperamide HCl 2 mg", "Ask a doctor before use if you have:": "fever mucus in the stool a history of liver disease a history of abnormal heart rhythm Ask a doctor before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:21.921307 · Updated: 2026-03-14T23:00:44.685211