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  5. Label Information: Imodium A-d

FDA Label for Imodium A-d

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH CAPLET)
    3. PURPOSE
    4. USE
    5. ALLERGY ALERT
    6. HEART ALERT
    7. OTC - DO NOT USE
    8. ASK A DOCTOR BEFORE USE IF YOU HAVE
    9. OTC - ASK DOCTOR/PHARMACIST
    10. OTC - WHEN USING
    11. STOP USE AND ASK A DOCTOR IF
    12. OTC - PREGNANCY OR BREAST FEEDING
    13. OTC - KEEP OUT OF REACH OF CHILDREN
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS OR COMMENTS?
    18. PRINCIPAL DISPLAY PANEL

Imodium A-d Product Label

The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. 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.

Other



Drug Facts


Active Ingredient (In Each Caplet)



Loperamide HCl 2 mg


Purpose



Anti-diarrheal


Use



controls symptoms of diarrhea, including Travelers' Diarrhea


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


Otc - Do Not Use



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
  • a history of abnormal heart rhythm

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.


Otc - When Using



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.

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - 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 (1-800-222-1222).


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; 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 (up to 33 lbs)do not use

Other Information



  • store at 20°-25°C (68°-77°F)
  • do not use if blister unit is broken or torn

Inactive Ingredients



anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch


Questions Or Comments?



1-877-895-3665 (toll-free) or215-273-8755 (collect)


Principal Display Panel



NDC 50580-317-06

Imodium®
A-D

Loperamide Hydrochloride Tablets, 2mg
Anti-Diarrheal

Anti-Diarrheal
Caplets

Controls the symptoms
of diarrhea

Actual Size

*Capsule-Shaped Tablets

12 Caplets*

Principal Display Panel - imodium 01

Principal Display Panel - imodium 01


* Please review the disclaimer below.