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  5. Label Information: Anti-diarrheal

FDA Label for Anti-diarrheal

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH CAPLET)
    3. PURPOSE
    4. USES
    5. REYE'S SYNDROME
    6. ALLERGY ALERT
    7. OTC - DO NOT USE
    8. OTC - ASK DOCTOR
    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 - 262 MG CAPLET BOTTLE CARTON

Anti-diarrheal Product Label

The following document was submitted to the FDA by the labeler of this product Lil' Drug Store Products, 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

Product distributed by: Lil' Drug Store Products, Inc.
9300 Earhart Lane SW, Cedar Rapids, IA 52404


Active Ingredient (In Each Caplet)



Bismuth subsalicylate 262 mg


Purpose



Upset stomach reliever and anti-diarrheal


Uses



relieves:

  • indigestion
  • nausea
  • heartburn
  • diarrhea
  • upset stomach associated with these symptoms

Reye's Syndrome



Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.


Allergy Alert



Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

Otc - Do Not Use



Do not use if you have

  • bloody or black stool
  • an ulcer
  • a bleeding problem

Otc - Ask Doctor



Ask a doctor before use if you have

  • fever
  • mucus in the stool

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking any drug for

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Otc - When Using



When using this product a temporary, but harmless darkening of the stool and/or tongue may occur.


Stop Use And Ask A Doctor If



  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

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 immediately.


Directions



  • swallow caplet(s) with water, do not chew
  • adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 caplets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other Information



  • each caplet contains: calcium 27 mg, salicylate 102 mg and sodium 2 mg
  • very low sodium
  • store at 59°-77°F (15°-25°C), in a dry place

Inactive Ingredients



calcium carbonate, colloidal silicon dioxide, D&C red 27 lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate


Questions Or Comments?



call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)


Principal Display Panel - 262 Mg Caplet Bottle Carton



QUALITY
⋆ GUARANTEED ⋆

Anti-
Diarrheal

Bismuth subsalicylate 262 mg

Upset Stomach Reliever/
Anti-diarrheal

* Please review the disclaimer below.