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  5. Label Information: Stomach Relief

FDA Label for Stomach Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. REYE'S SYNDROME
    5. ALLERGY ALERT
    6. OTC - DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Stomach Relief Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. 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

aerosil, beeswax, FD&C Red#33. FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl
cellulose, sorbitol solution, titanium dioxide


Otc - Purpose



Active ingredient                                                                                Purpose

(in each softgel)

Bismuth subsalicylate 262 mg...............Upset stomach reliever and anti-diarrheal


Uses



relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness

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

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

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 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 or last more than 2 days
  • 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 right away.


Directions



  • swallow with water, do not chew
  • adults and children 12 years and over:
  •  2 softgels (1 dose) every 1/2 hour or 4 softgels (2
    doses) every hour as needed for diarrhea
  • 2 softgels (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  •  do not exceed 8 doses (16 softgels) 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 softgel contains:
  •  salicylate 99 mg n very low sodium
  • store between 15-30°C (59-86°F)

Questions Or Comments?



1-888-333-9792


Principal Display Panel



Stomach Relief

BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER / ANTIDIARRHEAL

25 CT / 75 CT


* Please review the disclaimer below.