Heartland Pharma 44-375

Heartland Pharma 44-375
SPL v6
SPL
SPL Set ID e360ba61-556a-4d7f-ab2e-2cb71656d868
Route
ORAL
Published
Effective Date 2025-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (2 mg)
Inactive Ingredients
Starch, Corn D&c Yellow No. 10 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;375 Shape: oval Color: green Size: 10 mm Score: 2
Marketing Status
ANDA Active Since 2021-01-22

Description

Loperamide HCl 2 mg

Purpose

Anti-diarrheal


Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCl 2 mg

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

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.

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; 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



Do Not Use

if you have bloody or black stool.

Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store between 20º-25ºC (68º-77ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide



Questions Or Comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

NDC 80136-063-11

Heartland™

         Pharma Co.

ANTI-DIARRHEAL

Loperamide HCl Tablets, 2 mg

Anti-Diarrheal

Controls the symptoms

of Diarrhea

Compare to active

ingredient in IMODIUM® A-D*

24 Caplets

Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson &

Johnson Corporation, owner of the registered trademark

Imodium® A-D 50844 ORG061937508

Distributed by:

NORTHEAST PHARMA

South Burlington, VT 05403

www.heartlandpharmaco.com

1-800-383-0648



1.To open, tear at perforations and remove a section.

2. Use ✄ 
 to cut through plastic for caplet.

Heartland 44-375

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.

Active Ingredient (in Each Caplet)

Loperamide HCl 2 mg

Ask A Doctor Before Use If You Have
  • a 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.


Structured Label Content

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Purpose

Anti-diarrheal

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.

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; 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



Do Not Use (Do not use)

if you have bloody or black stool.

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store between 20º-25ºC (68º-77ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide



Questions Or Comments? (Questions or comments?)

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

NDC 80136-063-11

Heartland™

         Pharma Co.

ANTI-DIARRHEAL

Loperamide HCl Tablets, 2 mg

Anti-Diarrheal

Controls the symptoms

of Diarrhea

Compare to active

ingredient in IMODIUM® A-D*

24 Caplets

Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson &

Johnson Corporation, owner of the registered trademark

Imodium® A-D 50844 ORG061937508

Distributed by:

NORTHEAST PHARMA

South Burlington, VT 05403

www.heartlandpharmaco.com

1-800-383-0648



1.To open, tear at perforations and remove a section.

2. Use ✄ 
 to cut through plastic for caplet.

Heartland 44-375

When Using This Product, (When using this product,)

tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

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.

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

Loperamide HCl 2 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a 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.


Advanced Ingredient Data


Raw Label Data

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