SuperValu Inc. Loperamide Hydrochloride Oral Solution Drug Facts

Manufacturer
United Natural Foods, Inc. dba UNFI
Effective date
2025-04-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:59:09

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each 7.5 mL)

Loperamide HCl 1 mg

Purpose

Anti-diarrheal

Uses

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

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 And Dosage

Directions

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea • find right dose on chart. If possible, use weight to dose; otherwise use age. • shake well before using • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. • mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours children 9-11 years (60-95 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6-8 years (48-59 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours children 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use

Other Label Information

Other information

• each 30 mL contains: sodium 15 mg • store between 20-25 ° C (68-77 ° F)

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Questions or comments?

1-855-423-2630

Principal Display Panel

compare to Imodium ® A-D active ingredient EQUALINE ® loperamide hydrochloride oral solution, 1 mg per 7.5 mL (anti-diarrheal) controls the symptoms of diarrhea mint flavor anti-diarrheal oral solution 4 FL OZ (120mL)

Label Images

equaline-loperamide-hydrochloride-oral-solution-container-image
equaline-loperamide-hydrochloride-oral-solution-container-image

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredient (in each 7.5 mL)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 1 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Use

INDICATIONS & USAGE SECTION

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea • find right dose on chart. If possible, use weight to dose; otherwise use age. • shake well before using • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. • mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours children 9-11 years (60-95 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6-8 years (48-59 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours children 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use

Other information

STORAGE AND HANDLING SECTION

• each 30 mL contains: sodium 15 mg • store between 20-25 ° C (68-77 ° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-855-423-2630

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

compare to Imodium ® A-D active ingredient EQUALINE ® loperamide hydrochloride oral solution, 1 mg per 7.5 mL (anti-diarrheal) controls the symptoms of diarrhea mint flavor anti-diarrheal oral solution 4 FL OZ (120mL)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otcequaline-loperamide-hydrochloride-oral-solution-container-image.jpg2025-04-16
otcf973597f-df96-4cc9-8a94-f4335efe6d3e.xml2025-04-16
otc878bc762-0471-4b01-94de-d0cab9f5af08.xml2023-07-27
otc3eba6f42-62cc-42d8-a47c-9e260883e52d.xml2020-01-31
otc645EL-loperamide.jpg2020-01-31
otc645-el-loperamide-hydrochloride-oral-solution-1.jpg2018-06-06
otc645-el-loperamide-hydrochloride-oral-solution-2.jpg2018-06-06
otc645-el-loperamide-hydrochloride-oral-solution-3.jpg2018-06-06
otc9277f433-8b50-4b5b-bfe6-d257d89ebd90.xml2018-06-06