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Bismuth Subsalicylate Liquid Harris Teeter Disclaimer

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Bismuth Subsalicylate Liquid Harris Teeter Disclaimer STOMACH RELIEF - bismuth subsalicylate liquid Harris Teeter Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Drug Facts Active ingredient (in each 30 mL dose cup) Bismuth subsalicylate 525 mg Purposes Upset stomach reliever and antidiarrheal 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 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 (1-800-222-1222) right away. Directions shake well before use mL=milliliter measure only with dosing cup provided. Do not use any other dosing device adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed do not exceed 8 doses (240 mL) 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 30 mL dose cup contains: magnesium 12 mg, sodium 7 mg salicylate 233 mg low sodium Store at 20° to 25°C (68° to 77°F)and protect from freezing avoid excessive heat (over 104°F or 40°C) TAMPER EVIDENT: Do not use if the printed seal under the cap is missing or broken. Inactive ingredients benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, magnesium aluminum silicate type benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, magnesium aluminum silicate type 1C, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gum Questions or comments? 1-855-274-4122 * This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-BismolTM. PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (236 mL) Bottle Harris TeeterTM STOMACH RELIEF BISMUTH SUBSALICYLATE LIQUID Upset Stomach Reliever/Antidiarrheal Each 30 mL dose of oral solution contains: 525 mg bismuth subsalicylate 5-Symptom Digestive Relief: Heartburn Indigestion Nausea Upset stomach Diarrhea Compare to the active ingredient in Pepto-BismolTM* Original Flavor 8 FL OZ (236 mL) STOMACH RELIEF bismuth subsalicylate liquid Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:720 36 -0 0 6 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 6 2TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH 525 mg BISMUTH CATION - UNII:ZS9 CD1I8 YE) SUBSALICYLATE in 30 mL Inactive Ingredients Ingredient Name Strength BENZO IC ACID (UNII: 8 SKN0 B0 MIM) D&C Red No . 2 2 (UNII: 16 78 RKX8 RT) D&C Red No . 2 8 (UNII: 76 7IP0 Y5NH) MAGNESIUM ALUMINUM SILICATE TYPE IC (UNII: XLI9 KNX1FT) WATER (UNII: 0 59 QF0 KO0 R) SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY) SALICYLIC ACID (UNII: O414PZ4LPZ) SO DIUM SALICYLATE (UNII: WIQ1H8 5SYP) SO RBIC ACID (UNII: X0 45WJ9 8 9 B) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color PINK (Pink to Bright Pink) Score Shape Siz e Flavor WINTERGREEN Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:720 36 -0 0 6 -20 236 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 4/0 1/20 17 0 9 /0 1/20 22 2 NDC:720 36 -0 0 6 -16 354 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 4/0 1/20 17 0 9 /0 1/20 22 Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC MONOGRAPH FINAL part335 0 4/0 1/20 17 0 9 /0 1/20 22 Labeler - Harris T eeter (047279351) Establishment Name Addre ss ID/FEI Busine ss Ope rations Auro health LLC 0 78 728 447 MANUFACTURE(720 36 -0 0 6 ) Revised: 11/2020 Harris Teeter.
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