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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 CAPSULE)
    3. PURPOSE
    4. USE
    5. ALLERGY ALERT
    6. HEART ALERT
    7. 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 Capsule)



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


Do Not Use



  • if you have bloody or black stool
  • in children under 12 years of age

Ask A Doctor Before Use If You Have



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

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking antibiotics


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.


Directions



  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • not for use in children under 12 years of age
  • adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other Information



  • store at 20°-25°C (68°-77°F). Protect from light.
  • avoid excessive heat above 40°C (104°F)
  • do not use if carton or blister unit is open or torn

Inactive Ingredients



butylated hydroxyanisole, edible ink, FD&C blue no. 1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water


Questions Or Comments?



call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)


Principal Display Panel



NDC 50580-367-02

See New Warning

Imodium®
A-D
Loperamide HCl, 2mg/Anti-Diarrheal
Soft Gelatin Capsules

Anti-Diarrheal
Softgels

Controls the symptoms
of diarrhea

24 Softgels*
Actual Size

Suitable for adults and
children 12 years and over

*each liquid-filled capsule contains 2 mg loperamide HCl


* Please review the disclaimer below.