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  5. Label Information: Loperamide Hydrochloride

FDA Label for Loperamide Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPLET)
    2. PURPOSE
    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?
    16. PRINCIPAL DISPLAY PANEL

Loperamide Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Select Brand. 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.

Active Ingredient (In Each Caplet)



Loperamide HCI USP, 2 mg


Purpose



Anti-diarrheal


Uses



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 HCI


Do Not Use



If you have bloody or black stool


Ask A Doctor Before Use If You Have



  • fever
  • mucus in the stool
  • a history of liver disease

Ask A Doctor Or Pharmacist Before Use If You Are



Taking antibiotics


When Using This Product



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

Stop Use And Ask A Doctor If



  • diarrhea lasts for more than 2 days
  • symptoms get worse
  • 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.


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 over2 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;
    ½ 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;
    ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
    children under 6 years
    (up to 47 lbs)    		ask a doctor

Other Information



  • store between 20° – 25° C (68° – 77° F)
  • see side panel for lot number and expiration date
  • TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Inactive Ingredients



Anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch


Questions?



Call 1800-406-7984


Principal Display Panel



select brand®

NDC 15127-338-12

Loperamide Hydrochloride Tablets USP, 2 mg

ANTI-DIARRHEAL

Controls The Symptoms Of Diarrhea

٭Compare to the active ingredient of Imodium®A-D

12 Caplets*

Each Caplet (*capsule-shaped tablet) contains Loperamide HCl USP, 2 mg

5048836/R1109

This is the 12 count blister carton label for Select Brand Loperamide HCl tablets USP, 2 mg. - Loper

This is the 12 count blister carton label for Select Brand Loperamide HCl tablets USP, 2 mg. - Loper


* Please review the disclaimer below.