DailyMed - LOPERAMIDE HYDROCHLORIDE- loperamide hcl solution

NDC Code(s): 0904-6836-20
Packager: Major Pharmaceuticals

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 11, 2025

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Active ingredient (in each 7.5 mL)
Loperamide HCl 1 mg

Loperamide HCl 1 mg
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Purpose
Anti-diarrheal

Anti-diarrheal
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Use
controls symptoms of diarrhea, including Travelers’ Diarrhea

controls symptoms of diarrhea, including Travelers’ Diarrhea
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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 - Do not ...

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

Do not use

if you have bloody or black stool

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 or pharmacist before use if you are

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

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)

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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 ...

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

•

each 30 mL contains: sodium 15 mg

•

store between 20-25°C (68-77°F)

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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 ...

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
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Questions or comments?
1-800-719-9260

1-800-719-9260
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Package/Label Principal Display Panel
MAJOR® Compare to the active ingredient in Imodium® A-D - Loperamide Hydrochloride Oral Solution - 1 mg per 7.5 mL - Anti-Diarrheal - Controls the symptoms of diarrhea - Mint Flavor • Anti-Diarrheal Oral ...

MAJOR®

Compare to the active ingredient in Imodium® A-D

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 (120 mL)

SEE NEW WARNING AND DIRECTIONS

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INGREDIENTS AND APPEARANCE

Product Information

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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

Published Date (What is this?)	Version	Files
Apr 17, 2025	4 (current)	download
Feb 6, 2020	3	download
Dec 17, 2019	2	download
Nov 30, 2018	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1250685	loperamide HCl 1 MG in 7.5 mL Oral Suspension	PSN
2	1250685	loperamide hydrochloride 0.133 MG/ML Oral Suspension	SCD
3	1250685	loperamide HCl 1 MG per 7.5 ML Oral Solution	SY
4	1250685	loperamide hydrochloride 1 MG per 7.5 ML Oral Suspension	SY

Label: LOPERAMIDE HYDROCHLORIDE- loperamide hcl solution

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

Label: LOPERAMIDE HYDROCHLORIDE- loperamide hcl solution

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

LOPERAMIDE HYDROCHLORIDE- loperamide hcl solution

Number of versions: 4

LOPERAMIDE HYDROCHLORIDE- loperamide hcl solution

LOPERAMIDE HYDROCHLORIDE- loperamide hcl solution

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LOPERAMIDE HYDROCHLORIDE- loperamide hcl solution

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.