Anti-diarrheal Loperamide Hcl Tablet

SPL v4

SPL

SPL Set ID eec84fa1-262f-6e77-e053-2995a90a325b

Route

ORAL

Published

Effective Date 2022-12-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loperamide (2 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: 123 Shape: oval Color: green Size: 9 mm Score: 1

Marketing Status

ANDA Active Since 2016-07-27

Description

Loperamide HCl, USP 2 mg

Purpose

Anti-diarrheal

Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCl, USP 2 mg

Use

Controls symptoms of diarrhea, including Travelers’ Diarrhea

Section 42229-5

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc, McNeil Consumer Healthcare Divison, distributor of Imodium® A-D

Distributed by: Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404

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 hour

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

(up to 33 lbs)

do not use

Heart Alert

Heart alert:Taking more than directed can cause serious heart problems or death.

Do not use if you have bloody or black stool

Allergy Alert

Allergy alert:Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.

Other Information

Other information

■ store between 68-77°F (20-25°C)

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

2 Mg Loperamide Tablet

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

Diamode

Anti-Diarrheal Relief

Loperamide HCl

Tablets, USP 2 mg

[tablet image]

actual size

1 CAPLET IN EACH PACKET

READ DRUG FACTS AND INSTRUCTIONS ON PACKET

Questions Or Comments?

Call 1-800-351-2000 (8:30 AM - 5:00 PM CST)

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 Tablet)

Loperamide HCl, 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

Ask A Doctor Or Pharmacist Before Use If You Are

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

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

Structured Label Content

Use

Controls symptoms of diarrhea, including Travelers’ Diarrhea

Section 42229-5 (42229-5)

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc, McNeil Consumer Healthcare Divison, distributor of Imodium® A-D

Distributed by: Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404

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 hour

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

(up to 33 lbs)

do not use

Heart Alert (Heart alert)

Heart alert:Taking more than directed can cause serious heart problems or death.

Do not use if you have bloody or black stool

Allergy Alert (Allergy alert)

Allergy alert:Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.

Other Information

Other information

■ store between 68-77°F (20-25°C)

Inactive Ingredients

2 Mg Loperamide Tablet (2 mg Loperamide Tablet)

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

Diamode

Anti-Diarrheal Relief

Loperamide HCl

Tablets, USP 2 mg

[tablet image]

actual size

1 CAPLET IN EACH PACKET

READ DRUG FACTS AND INSTRUCTIONS ON PACKET

Questions Or Comments? (Questions or Comments?)

Call 1-800-351-2000 (8:30 AM - 5:00 PM CST)

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 Tablet) (Active Ingredient ( in each tablet))

Loperamide HCl, 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

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.

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

Advanced Ingredient Data

[{"name": "POWDERED CELLULOSE", "unii": "SMD1X3XO9M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "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": "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": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "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": "*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc, McNeil Consumer Healthcare Divison, distributor of Imodium® A-D Distributed by: Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404", "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 hour 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 (up to 33 lbs) do not use", "Heart alert": "Heart alert: Taking more than directed can cause serious heart problems or death. Do not use if you have bloody or black stool", "Allergy alert": "Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.", "Other Information": "Other information ■ store between 68-77°F (20-25°C)", "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", "2 mg Loperamide Tablet": "Compare to the active ingredient in Imodium® A-D* Diamode Anti-Diarrheal Relief Loperamide HCl Tablets, USP 2 mg [tablet image] actual size 1 CAPLET IN EACH PACKET READ DRUG FACTS AND INSTRUCTIONS ON PACKET", "Questions or Comments?": "Call 1-800-351-2000 (8:30 AM - 5:00 PM CST)", "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 tablet)": "Loperamide HCl, 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", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:11.051162 · Updated: 2026-03-14T23:06:36.654428