Stomach Relief Softgels

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Active ingredient ( in each softgel)                        Purpose

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

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

taking any drug for

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

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 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 right away.

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 102 mg
• very low sodium
•  do not exceed 25°C

Inactive ingredients

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