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  5. Label Information: Stomach Relief

FDA Label for Stomach Relief

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE IF YOU HAVE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. POUCH

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.

Drug Facts




Active Ingredient (In Each Tablet)



Bismuth subsalicylate 262 mg


Purpose



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


Warnings



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


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


Ask A Doctor Or Pharmacist Before Use If You Are If You Are



you are taking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis


When Using This Product



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


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. (1-800-222-1222)


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 soft gels (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 • very low sodium • store between 15–30°C (59–86°F)


Inactive Ingredients



Aerosil, beeswax, FD&C Red No. 33, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl cellulose, sorbitol solution, titanium dioxide


Questions Or Comments?



1-888-333-9792


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