Stomach Relief
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each softgel)
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
OTC - DO NOT USE SECTION
Do not use if you have • an ulcer • a bleeding problem • bloody or black stool
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have • fever • mucus in the stool
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking any drug for
• any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis
OTC - WHEN USING SECTION
When using this product • a temporary, but harmless, darkening of the stool and/or tongue may occur
OTC - STOP USE SECTION
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 SECTION
If pregnant or breast-feeding,ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
Directions
• swallow with water, do not chew • adults and children 12 years and over: • 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea • 2 softgels every ½ hour to 1 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 20-25° C (68-77° F)
Inactive ingredients
FD&C red #33, gelatin, glycerin, lecithin, polyethylene glycol-400, polysorbate 80, povidone, sorbitan, titanium dioxide
SPL UNCLASSIFIED SECTION
Distributed by: Shield Pharmaceuticals Corp. Hauppauge, NY 11788