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  5. Label Information: Loperamide Hydrochloride And Simethicone

FDA Label for Loperamide Hydrochloride And Simethicone

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 MG/125MG (24 CAPLETS) BLISTER CARTON LABEL

Loperamide Hydrochloride And Simethicone Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Co.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)


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WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

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MADE IN INDIA


Code: AP/DRUGS/04/2016


Package Label-Principal Display Panel - 2 Mg/125Mg (24 Caplets) Blister Carton Label



NDC 0363-9606-76

Walgreens

Compare to the active ingridients in
Imodium® Multi-Sympton Relief††


Anti - Diarrheal +
Anti - Gas
LOPERAMIDE HCl & SIMETHICONE TABLETS, 2 mg/125 mg
ANTI-DIARRHEAL / ANTI-GAS

Multi-Symptom Relief Caplet
 •    Relieves symptoms of diarrhea plus:
        Cramps & Pressure; Bloating; Gas

24 CAPLETS*                                       ACTUAL SIZE
(*capsule-shaped tablets)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (24 Caplets) Blister Carton Label - loper fig1

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (24 Caplets) Blister Carton Label - loper fig1



* Please review the disclaimer below.