Loperamide HCl 2 mg/1

Loperamide HCl · TABLET · L.N.K. International, Inc.

2 Recalls on Record

Plain English

Loperamide HCl is a tablet containing loperamide hcl at 2 mg/1, taken oral. Manufactured by L.N.K. International, Inc..

Key Facts

Brand Name: Loperamide HCl
Generic Name: Loperamide HCl
NDC Code (Product): 50844-735
Manufacturer: L.N.K. International, Inc.
Strength: 2 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA076497
Marketing Start: 05/03/2005

Recall History

2 Recalls on Record

Class III12/26/2018

Sun Pharmaceutical Industries, Inc.

Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.

TerminatedVoluntary: Firm initiated

Class III05/17/2012

Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.

Defective Container; damaged blister units

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea1,606 reports

drug ineffective1,320 reports

off label use989 reports

nausea917 reports

intentional product use issue867 reports

fatigue757 reports

constipation574 reports

pyrexia555 reports

vomiting548 reports

weight decreased468 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Dosage & Administration

Directions • drink plenty of clear fluids to help prevent dehydration caused by diarrhea • take only on an empty stomach (1 hour before or 2 hours after a meal) • take with a full (8 oz.) glass of water • find right dose on chart below. 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 to 47 lbs) ask a doctor children under 2 years (upto 33 lbs) do not use Other information • calcium: contains 142 mg/caplet • store between 20-25° C (68-77° F). Protect from light. • TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Warnings

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 Do not use • if you have bloody or black stool • if you have difficulty swallowing 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. • you have difficulty swallowing the caplet 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 (1800-222-1222).

Frequently Asked Questions

What is Loperamide HCl used for?

Loperamide HCl contains Loperamide HCl. It is a tablet taken oral. Consult your doctor for specific uses.

Is Loperamide HCl a controlled substance?

Loperamide HCl is not classified as a controlled substance by the DEA.

What is the generic name for Loperamide HCl?

The generic name for Loperamide HCl is Loperamide HCl. There are 12 other brand versions of Loperamide HCl.

What is the NDC code for Loperamide HCl 2 mg/1?

The NDC (National Drug Code) for Loperamide HCl 2 mg/1 is 50844-735, listed by L.N.K. International, Inc..

Product NDC

50844-735

Package NDC

50844-735-02

Other Loperamide Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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