STORAGE AND HANDLING SECTION.
Other Information. each Tbsp (15 mL) contains: sodium mglow sodiumsugar freesalicylate 145 mgmay not meet USP requirements for pHpink colored, peppermint flavored liquid supplied in the following oral dosage form: NDC 0121-4803-30 (unit dose cups of 30 mL). store at 20 to 25C (68 to 77F). Protect from freezing.. each Tbsp (15 mL) contains: sodium mg. low sodium. sugar free. salicylate 145 mg. may not meet USP requirements for pH. pink colored, peppermint flavored liquid supplied in the following oral dosage form: NDC 0121-4803-30 (unit dose cups of 30 mL). store at 20 to 25C (68 to 77F). Protect from freezing.
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DOSAGE & ADMINISTRATION SECTION.
Directions. shake well before use.adults and children 12 years and over: dose (2 Tbsp or 30 mL) every 1/2 to hour as neededdo not exceed doses (16 Tbsp or 240 mL) 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.. shake well before use.. adults and children 12 years and over: dose (2 Tbsp or 30 mL) every 1/2 to hour as needed. do not exceed doses (16 Tbsp or 240 mL) 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.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. D&C Red No. 22, D&C Red No. 28, methyl salicylate, peppermint flavor, potassium sorbate, purified water, salicylic acid, sodium benzoate, sodium saccharin, sodium salicylate, veegum and xanthan gum.
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INDICATIONS & USAGE SECTION.
Uses. relieves:heartburnindigestionupset stomachnauseadiarrhea(Also relieves travelers diarrhea and gas, belching, and fullness due to overindulgence with food and drink.). heartburn. indigestion. upset stomach. nausea. diarrhea.
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OTC - ACTIVE INGREDIENT SECTION.
Active Ingredient (in each 15 mL tablespoon). Bismuth subsalicylate 262 mg.
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OTC - ASK DOCTOR SECTION.
Ask doctor before use if you have. fevermucus in the stool. fever. mucus in the stool.
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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.
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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.
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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 right away.
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OTC - PREGNANCY OR BREAST FEEDING SECTION.
If pregnant or breast-feeding, ask health professional before use.
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OTC - PURPOSE SECTION.
Purposes. upset stomach reliever and antidiarrheal.
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OTC - QUESTIONS SECTION.
Questions or comments. Call 1-800-845-8210.
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OTC - STOP USE SECTION.
Stop use and ask doctor if. symptoms get worseringing in the ears or loss of hearing occursdiarrhea lasts more than days. symptoms get worse. ringing in the ears or loss of hearing occurs. diarrhea lasts more than days.
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OTC - WHEN USING SECTION.
When using this product temporary, but harmless, darkening of the stool and/or tongue may occur.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL Unit Dose Cup Label. Delivers 30 mL NDC 0121-4803-30 INK ISMUTH (Bismuth Subsalicylate Oral Suspension) 524 mg/30 mLSHAKE WELL FOR INSTITUTIONAL USE ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERTA48033001. Principal Display Panel Unit Dose Cup Label.
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SPL UNCLASSIFIED SECTION.
Drug Facts.
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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 or 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 have. fevermucus 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 if. symptoms get worseringing in the ears or loss of hearing occursdiarrhea lasts more than days. symptoms get worse. 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 right away.
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