Label: KROGER REGULAR STRENGTH PINK BISMUTH- bismuth subsalicylate suspension
- NDC Code(s): 30142-608-08, 30142-608-12
- Packager: KROGER COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated August 23, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each 30 mL dose)
- Purposes
- Uses
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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 or 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
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- allergic to salicylates (including aspirin)
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- taking other salicylate products
Ask a doctor or pharmacist before use if you are
taking any drug for
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- anticoagulation (thinning the blood)
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- diabetes
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- gout
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- arthritis
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Directions
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- shake well before use
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- only use dose cup provided
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- adults and children 12 years and over: 30 mL 1 (dose) every 1/2 hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea
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- 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
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- do not exceed 8 doses (240 mL) in 24 hours
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- use until diarrhea stops but not more than 2 days
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- children under 12 years: ask a doctor
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- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
*COMPARE TO the active ingredient in PEPTO-BISMOL® REGULAR STRENGTH *See side panel
Regular Strength
Stomach Relief
Bismuth Subsalicylate 525 mg
Upset Stomach Reliever/Antidiarrheal
Original Flavor
5 SYMPTOM RELIEF
RELIEF:
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- Heartburn
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- Indigestion
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- Nausea
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- Upset Stomach
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- Diarrhea
*This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-Bismol® Regular Strength.
Package Label 236 mL
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INGREDIENTS AND APPEARANCE
KROGER REGULAR STRENGTH PINK BISMUTH
bismuth subsalicylate suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-608 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 525 mg in 30 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) D&C RED NO. 22 (UNII: 1678RKX8RT) D&C RED NO. 28 (UNII: 767IP0Y5NH) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SALICYLIC ACID (UNII: O414PZ4LPZ) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color PINK (viscous) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-608-08 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 2 NDC:30142-608-12 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 03/30/2020 Labeler - KROGER COMPANY (006999528)