major pharmaceuticals loperamide hydrochloride oral solution drug facts

SPL v5

SPL

SPL Set ID cf5dc855-f0cc-4d7e-8d15-472f7e654409

Route

oral

Published

Effective Date 2026-02-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

loperamide (1 mg)

Inactive Ingredients

anhydrous citric acid carboxymethylcellulose sodium, unspecified d&c yellow no. 10 fd&c blue no. 1 glycerin microcrystalline cellulose propylene glycol water sodium benzoate sucralose titanium dioxide xanthan gum dimethicone silicon dioxide

Identifiers & Packaging

Pill Appearance

Color: green

Marketing Status

anda active Since 2018-11-29

Purpose

Anti-diarrheal

Description

Loperamide HCl 1 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
•
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

•
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

Description

Loperamide HCl 1 mg

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Do Not Use

if you have bloody or black stool

Questions Or Comments?

1-800-719-9260

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

Active Ingredient (in Each 7.5 Ml)

Loperamide HCl 1 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

Package/label Principal Display Panel

MAJOR^®

compare to the active ingredient in Imodium^® A-D

loperamide hydrochloride oral solution

loperamide hydrochloride oral solution 1 mg per 7.5 mL

anti-diarrheal oral solution

controls the symptoms of diarrhea

anti-diarrheal oral solution

4 fl oz (120 mL)

mint flavor

Ask A Doctor Or Pharmacist 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
•
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 (Other information)

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

Inactive Ingredients (Inactive ingredients)

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Do Not Use (Do not use)

if you have bloody or black stool

Questions Or Comments? (Questions or comments?)

1-800-719-9260

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

Active Ingredient (in Each 7.5 Ml) (Active ingredient (in each 7.5 mL))

Loperamide HCl 1 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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

MAJOR^®

compare to the active ingredient in Imodium^® A-D

loperamide hydrochloride oral solution

loperamide hydrochloride oral solution 1 mg per 7.5 mL

anti-diarrheal oral solution

controls the symptoms of diarrhea

anti-diarrheal oral solution

4 fl oz (120 mL)

mint flavor

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

taking a prescription drug. Loperamide may interact with certain prescription drugs.

Advanced Ingredient Data

[{"name": "LOPERAMIDE", "unii": "6X9OC3H4II", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "7.5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "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": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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 • 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", "Do not use": "if you have bloody or black stool", "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?": "1-800-719-9260", "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 for 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 right away. (1-800-222-1222)", "Active ingredient (in each 7.5 mL)": "Loperamide HCl 1 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", "Package/Label Principal Display Panel": "MAJOR ® compare to the active ingredient in Imodium ® A-D loperamide hydrochloride oral solution loperamide hydrochloride oral solution 1 mg per 7.5 mL anti-diarrheal oral solution controls the symptoms of diarrhea anti-diarrheal oral solution 4 fl oz (120 mL) mint flavor", "Ask a doctor or pharmacist 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: 2026-02-15T12:05:54.972550 · Updated: 2026-03-14T23:13:44.961646