OTC - QUESTIONS SECTION.

Questions. 1-866-467-2748.

OTC - PURPOSE SECTION.

Purpose. Upset stomach reliever and anti-diarrheal.

DOSAGE & ADMINISTRATION SECTION.

Directions. swallow with water, do not chewadults and children 12 years and over: caplet (1 dose) every 1/2 hour or caplets (2 doses) every hour as needed for diarrhea1 caplet (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)do not exceed doses (8 caplets) in 24 hoursuse until diarrhea stops but not more than dayschildren under 12 years: ask doctordrink plenty of clear fluids to help prevent dehydration caused by diarrhea. swallow with water, do not chew. adults and children 12 years and over: caplet (1 dose) every 1/2 hour or caplets (2 doses) every hour as needed for diarrhea. caplet (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea). do not exceed doses (8 caplets) in 24 hours. use until diarrhea stops but not more than days. children under 12 years: ask doctor. drink plenty of clear fluids to help prevent dehydration caused by diarrhea.

INACTIVE INGREDIENT SECTION.

Inactive ingredients. calcium carbonate, crospovidone, FD&C Red No. 27 Lake, magnesium stearate, microcrystalline cellulose, polysorbate 80, sodium lauryl sulphate.

INDICATIONS & USAGE SECTION.

Uses. relievestravelers diarrheadiarrheaupset stomach due to overindulgence in food and drink, including: heartburnindigestionnauseagasbelchingfullness. travelers diarrhea. diarrhea. upset stomach due to overindulgence in food and drink, including: heartburnindigestionnauseagasbelchingfullness. heartburn. indigestion. nausea. gas. belching. fullness.

OTC - ACTIVE INGREDIENT SECTION.

Active ingredient (in each caplet). Bismuth Subsalicylate 525 mg.

OTC - ASK DOCTOR SECTION.

Ask doctor before use if you havefevermucus in the stool. fever. mucus in the stool.

OTC - ASK DOCTOR/PHARMACIST SECTION.

Ask doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning the blood)diabetesgoutarthritis. anticoagulation (thinning the blood). diabetes. gout. arthritis.

OTC - DO NOT USE SECTION.

Do not use if you have an ulcera bleeding problembloody or black stool. an ulcer. bleeding problem. bloody or black stool.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center immediately at 1-800-222-1222.

OTC - PREGNANCY OR BREAST FEEDING SECTION.

If pregnant or breast feeding, ask health professional before use.

OTC - STOP USE SECTION.

Stop use and ask doctor ifsymptoms get worse or last more than daysringing in the ears or loss of hearing occursdiarrhea lasts more than days. symptoms get worse or last more than days. ringing in the ears or loss of hearing occurs. diarrhea lasts more than days.

OTC - WHEN USING SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 24 Caplet Carton. Compare to the active Ingredient in Pepto-Bismosol(R) Ultra CapletsNDC 0363-1302-02Ultra StrengthDigestive Relief Bismuth Subsalicylate Upset Stomach Reliever/Antidiarrheal Symptom Digestive ReliefoHeartburnoIndigestionoNauseaoUpset StomachoDiarrhea 2X CONCENTRATED FORMULA24 Caplets. oHeartburn. oIndigestion. oNausea. oUpset Stomach. oDiarrhea. Ultra Strength Digestive Relief 24 Caplets.

SPL UNCLASSIFIED SECTION.

Drug Facts.

STORAGE AND HANDLING SECTION.

Other information. each caplet contains: calcium 54 mgsalicylate 199 mgvery low sodiumstore at room temperature. each caplet contains: calcium 54 mg. salicylate 199 mg. very low sodium. store at room temperature.

WARNINGS SECTION.

Warnings. Reyes 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 doctor because these symptoms could be an early sign of Reyes syndrome, rare but serious illness.. Allergy alert. Contains salicylate. Do not take if you areallergic to salicylates (including aspirin)taking other salicylate products. allergic to salicylates (including aspirin). taking other salicylate products. Do not use if you have an ulcera bleeding problembloody or black stool. an ulcer. bleeding problem. bloody or black stool. Ask doctor before use if you havefevermucus in the stool. fever. mucus in the stool. Ask doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning the blood)diabetesgoutarthritis. anticoagulation (thinning the blood). diabetes. gout. arthritis. When using this product temporary, but harmless, darkening of the stool and/or tongue may occur Stop use and ask doctor ifsymptoms get worse or last more than daysringing in the ears or loss of hearing occursdiarrhea lasts more than days. symptoms get worse or last more than days. ringing in the ears or loss of hearing occurs. diarrhea lasts more than days. If pregnant or breast feeding, ask health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center immediately at 1-800-222-1222.