IBS LABS - ANTI-DIARRHEAL

Manufacturer
YYBA
Effective date
2023-05-25
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 21:30:52

Label at a glance#

ProductIBS LABS - ANTI-DIARRHEAL ORIGINAL PRESCRIPTION STRENGTH, 2 MG
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

drink plenty of clear liquids to help prevent dehydration caused by diarrhea find the right dose on chart. If possible, use weight to dose, otherwise use age. adults and children 12 years and over 2 caplets after the first loose stool, 1 caplet after each subsequent loose stool, but no more that 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool, 1/2 caplet after each subseq...

Storage and handling

store between 20° and 25°C (68° and 77°F)

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 2 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

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink plenty of clear liquids to help prevent dehydration caused by diarrhea
  • find the right dose on chart. If possible, use weight to dose, otherwise use age.
adults and children 12 years and over2 caplets after the first loose stool, 1 caplet after each subsequent loose stool, but no more that 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 to 47 lbs)ask a doctor
children under 2 years (up to 33 lbs)do not use

Other information

STORAGE AND HANDLING SECTION

  • store between 20° and 25°C (68° and 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate,
microcrystalline cellulose, silica gel

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-866-933-6337

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73581-77773581-777-96, 73581-777-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0e137aa6-12e6-9487-e063-6294a90a4dd9fb4bf352-23a2-5c49-e053-6294a90aa05d2024-01-03WarningsExact identifier
spl set id: fb4bf352-23a2-5c49-e053-6294a90aa05d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.