Label: QC PINK BISMUTH STOMACH RELIEF- bismuth subsalicylate tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 63868-705-30 - Packager: CHAIN DRUG MARKETING ASSOCIATION
- 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 January 18, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- 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 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
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- allergic to salicylates (including aspirin)
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- taking other salicylate products
Do not use if you have
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- an ulcer
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- a bleeding problem
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- bloody or black stool
Ask a doctor before use if you have
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- fever
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- mucus in the stool
Ask a doctor or pharmacist before use if you are taking any drug for
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- anticoagulation (thinning of 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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- chew completely or dissolve tablets in mouth.
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- adults and children 12 years and older: 2 tablets (1 dose) every ½ hour to 1 hour as needed for diarrhea
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- 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
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- do not exceed 8 doses (16 tablets) 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 clear fluids to help prevent dehydration caused by diarrhea.
- Other information
- Inactive ingredients
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Principal Display
QUALITY CHOICE®
NDC# 63868-705-30
*Compare to the active ingredient in Pepto-Bismol® Chewables*
Pink Bismuth
Stomach Relief
Bismuth Subsalicylate
Upset Stomach Reliever/Antidiarrheal
5 Symptom Digestive Relief
Heartburn
Indigestion
Nausea
Upset Stomach
Diarrhea
Original Flavor
30 Chewable Tablets
QC SATISFACTION GUARANTEED
DISTRIBUTED BY:
C.D.M.A., Inc.
43157 W. Nine Mile
Novi, MI 48376-0995
Questions: 248-449-9300
*This product is not manufactured or distributed by PROCTER & GAMBLE INC., the distributor of Pepto-Bismol®
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INGREDIENTS AND APPEARANCE
QC PINK BISMUTH STOMACH RELIEF
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-705 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) D&C RED NO. 27 (UNII: 2LRS185U6K) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color PINK Score no score Shape ROUND Size 17mm Flavor Imprint Code RP124 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-705-30 5 in 1 CARTON 02/24/2020 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 02/24/2020 Labeler - CHAIN DRUG MARKETING ASSOCIATION (011920774)