heartland pharma 44-375
e360ba61-556a-4d7f-ab2e-2cb71656d868
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Anti-diarrheal
Description
Loperamide HCl 2 mg
Medication Information
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.
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; 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 |
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
Description
Loperamide HCl 2 mg
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.
Use
controls symptoms of diarrhea, including Travelers’ Diarrhea
Do Not Use
if you have bloody or black stool.
Questions Or Comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
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
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.
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; 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 |
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
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.
Use
controls symptoms of diarrhea, including Travelers’ Diarrhea
Do Not Use (Do not use)
if you have bloody or black stool.
Questions Or Comments? (Questions or comments?)
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
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
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:54.202395 · Updated: 2026-03-14T23:08:19.346855