DailyMed - ANTI-DIARRHEAL- loperamide hydrochloride tablet

NDC Code(s): 80513-401-24
Packager: Advanced Rx LLC

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

Drug Label Information

Updated August 11, 2024

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

Active ingredient (in each caplet)
Loperamide HCl 2 mg

Loperamide HCl 2 mg
Close
Purpose
Anti-diarrheal

Anti-diarrheal
Close
Use
Controls symptoms of diarrhea, including Travelers' Diarrhea

Controls symptoms of diarrhea, including Travelers' Diarrhea
Close
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 ...
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 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 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.

Close

Directions

drink plenty of clear liquid to help prevent dehydration caused by diarrhea - find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years ...

Other information
do not use if seal around caplet is broken or damaged - store between 20° and 25°C (68° and 77°F) KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION - THIS PRODUCT IS PACKAGED IN A ...
- do not use if seal around caplet is broken or damaged
- store between 20° and 25°C (68° and 77°F)
- KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
- THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TEMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
Close
Inactive ingredients
corn starch, D&C yellow#10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue#1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel.

corn starch, D&C yellow#10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue#1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel.
Close
Questions?
call toll-free - 1-800-630-8895

call toll-free 1-800-630-8895
Close
SPL UNCLASSIFIED SECTION
Distributed by: ADVANCED RX LLC, 1942 NE 163rd St, North Miami Beach, FL 33162 U.S.A.

Distributed by:

ADVANCED RX LLC,

1942 NE 163rd St,

North Miami Beach,

FL 33162 U.S.A.
Close
Principal Display Panel
NDC 80513-401-24 - Compare to the active ingredient in - Imodium - ®A-D* Anti-Diarrheal - Loperamide Hydrocholoride Caplets, 2 mg - Controls Symptoms of Diarrhea - Easy To ...

NDC 80513-401-24

Compare to the active ingredient in Imodium ®A-D*

Anti-Diarrheal

Loperamide Hydrocholoride Caplets, 2 mg

Controls Symptoms of Diarrhea

Easy To Swallow

24 CAPLETS

*This product is not manufactured or distributed by the owner of the registered trademark Imodium ®A-D.

Close

INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	manufacture(80513-401) , label(80513-401) , pack(80513-401)

View All Sections

adults and children 12 years and over	2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs)	1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs)	1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children 2-5 years (34-47 lbs)	ask a doctor
children under 2 years (up to 33 lbs)	do not use

	RxCUI	RxNorm NAME	RxTTY
1	978010	loperamide HCl 2 MG Oral Tablet	PSN
2	978010	loperamide hydrochloride 2 MG Oral Tablet	SCD

Label: ANTI-DIARRHEAL- loperamide hydrochloride tablet

View Package Photos

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 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: ANTI-DIARRHEAL- loperamide hydrochloride tablet

View Package Photos

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 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

ANTI-DIARRHEAL- loperamide hydrochloride tablet

Number of versions: 1

ANTI-DIARRHEAL- loperamide hydrochloride tablet

ANTI-DIARRHEAL- loperamide hydrochloride tablet

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

ANTI-DIARRHEAL- loperamide hydrochloride tablet

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