Loperamide Hydrochloride And Simethicone Tablet
FDA Label NDC 58602-815

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Loperamide Hydrochloride And Simethicone (NDC 58602-815). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredients (in each caplet) 

Loperamide HCl USP 2 mg
Simethicone USP 125 mg

Purposes

Anti-diarrheal
Anti-gas

Uses

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

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.

(1-800-222-1222)

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 to 11 years (60 to 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 to 8 years (48 to 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 to 5 years (34 to 47 lbs)
    		ask a doctor
    children under 2 years (up to 33 lbs)
    		do not use

Other Information

  • each caplet contains: calcium 165 mg, sodium 4 mg
  • store between 20° to 25°C (68° to 77°F). Protect from light.
  • do not use if carton is opened or if individual blister units are torn or opened

Inactive Ingredients

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate anhydrous, flavor, microcrystalline cellulose, stearic acid.

Questions Or Comments?

call 1-855-274-4122

(Monday – Friday 8:30 AM to 5:00 PM EST)


Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648


Made in India


Code: AP/DRUGS/04/2016

Package Label-Principal Display Panel - 2 Mg/125Mg (12 Caplets) Blister Carton Label

AUROHEALTH

NDC 58602-815-75
** Compare to the active
ingridients of  Imodium® Multi-Sympton Relief

Loperamide HCl and
Simethicone Tablets
2 mg/125 mg

Loperamide HCl 2 mg - Antidiarrheal 
Simethicone 125 mg - Anti-gas
Multi-Sympton Relief
Caplet
Relieves symptoms of diarrhea plus

•  Cramps & Pressure
•   Bloating
•  Gas   

12 Caplets*
*capsule-shaped tablets

Package Label-principal Display Panel (2 mg/125mg (12 Caplets) Blister Carton Label)

Package Label-principal Display Panel (2 mg/125mg (12 Caplets) Blister Carton Label)

* Please review the disclaimer below.