Loperamide Hydrochloride

SPL v4

SPL

SPL Set ID 07e1f89c-5bf6-4539-848a-4435e7deb0d2

Route

ORAL

Published

Effective Date 2019-06-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loperamide (2 mg)

Inactive Ingredients

Anhydrous Lactose Croscarmellose Sodium Crospovidone (15 Mpa.s At 5%) D&c Yellow No. 10 Fd&c Blue No. 1 Hydrogenated Cottonseed Oil Magnesium Stearate Powdered Cellulose Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: 123 Shape: capsule Color: green Size: 9 mm Score: 2

Marketing Status

ANDA Active Since 2014-01-16

Description

Drug Facts

Purpose

Anti-diarrheal

Medication Information

Purpose

Anti-diarrheal

Description

Drug Facts

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50567-7

When using this producttiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking a prescription drug. Loperamide may interact with certain prescription drugs.

Section 50570-1

Do not useif you have bloody or black stool

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

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.

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; ½ 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; ½ 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

Questions?

Call toll-free Monday-Friday 8:30 am to 5 pm EST at 1800-406-7984.

Heart Alert

Taking more than directed can cause serious heart problems or death

Allergy Alert

Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride

Other Information

store between 20° – 25°C (68° – 77°F)
see side panel for lot number and expiration date
TAMPER EVIDENT: THIS PRODUCT IS PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Inactive Ingredients

anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

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.

Active Ingredient (in Each Caplet)

Loperamide Hydrochloride USP, 2 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

Principal Display Panel 2 Mg Caplet Blister Pack Carton

COMPARE TO THE

ACTIVE INGREDIENT IN

IMODIUM ^®A-D**

ZEE _®

Loperamide Hydrochloride

Tablets USP, 2 mg

Anti-Diarrheal

See New Warnings

and Directions

12 Caplets*

Each caplet (*capsule-shaped tablet)

contains Loperamide Hydrochloride USP, 2 mg

Controls the Symptoms

of Diarrhea

Structured Label Content

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50567-7 (50567-7)

When using this producttiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking a prescription drug. Loperamide may interact with certain prescription drugs.

Section 50570-1 (50570-1)

Do not useif you have bloody or black stool

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

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.

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; ½ 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; ½ 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

Questions?

Call toll-free Monday-Friday 8:30 am to 5 pm EST at 1800-406-7984.

Heart Alert (Heart alert)

Taking more than directed can cause serious heart problems or death

Allergy Alert (Allergy alert)

Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride

Other Information (Other information)

store between 20° – 25°C (68° – 77°F)
see side panel for lot number and expiration date
TAMPER EVIDENT: THIS PRODUCT IS PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Inactive Ingredients (Inactive ingredients)

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.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Loperamide Hydrochloride USP, 2 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

Principal Display Panel 2 Mg Caplet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 2 mg Caplet Blister Pack Carton)

COMPARE TO THE

ACTIVE INGREDIENT IN

IMODIUM ^®A-D**

ZEE _®

Loperamide Hydrochloride

Tablets USP, 2 mg

Anti-Diarrheal

See New Warnings

and Directions

12 Caplets*

Each caplet (*capsule-shaped tablet)

contains Loperamide Hydrochloride USP, 2 mg

Controls the Symptoms

of Diarrhea

Advanced Ingredient Data

[{"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE (15 MPA.S AT 5%)", "unii": "68401960MK", "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": "HYDROGENATED COTTONSEED OIL", "unii": "Z82Y2C65EA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POWDERED CELLULOSE", "unii": "SMD1X3XO9M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LOPERAMIDE", "unii": "6X9OC3H4II", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "controls symptoms of diarrhea, including Travelers' Diarrhea", "42229-5": "Drug Facts", "50565-1": "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).", "50567-7": "When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.", "50568-5": "Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.", "50570-1": "Do not use if you have bloody or black stool", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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. 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; ½ 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; ½ 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", "Questions?": "Call toll-free Monday-Friday 8:30 am to 5 pm EST at 1800-406-7984 .", "Heart alert": "Taking more than directed can cause serious heart problems or death", "Allergy alert": "Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride", "Other information": "store between 20° – 25°C (68° – 77°F) see side panel for lot number and expiration date TAMPER EVIDENT: THIS PRODUCT IS PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.", "Inactive ingredients": "anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch", "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.", "Active ingredient (in each caplet)": "Loperamide Hydrochloride USP, 2 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", "PRINCIPAL DISPLAY PANEL - 2 mg Caplet Blister Pack Carton": "COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM ® A-D** ZEE ® Loperamide Hydrochloride Tablets USP, 2 mg Anti-Diarrheal See New Warnings and Directions 12 Caplets* Each caplet (*capsule-shaped tablet) contains Loperamide Hydrochloride USP, 2 mg Controls the Symptoms of Diarrhea"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:40.683418 · Updated: 2026-03-14T23:02:21.986500