Label: QC PINK BISMUTH- bismuth subsalicylate tablet, film coated
- NDC Code(s): 63868-171-40
- Packager: QUALITY CHOICE (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.
Updated January 21, 2021
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- Drug Facts
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.
Ask a doctor or pharmacist before use if you are
taking any drug for
- anticoagulation (thinning the blood)
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
- swallow with water, do not chew
- adults and children 12 years and older: 2 caplets every 1/2 to 1 hour as needed
- do not exceed 8 doses (16 caplets) 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
- Questions or comments?
PRINCIPAL DISPLAY PANEL
Compare to Pepto-Bismol® Regular Strength the active ingredient*
Bismuth Subsalicylate 262mg
Upset stomach Indigestion, Nausea, Heartburn, Diarrhea
Package Contains One Bottle
QC SATISFACTION GUARANTEED
Distributed by C.D.M.A., Inc.
43157 W. Nine Mile
Novi MI 48376-0995
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®.
INGREDIENTS AND APPEARANCE
QC PINK BISMUTH
bismuth subsalicylate tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-171 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 CALCIUM CARBONATE (UNII: H0G9379FGK) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) D&C RED NO. 27 (UNII: 2LRS185U6K) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color WHITE Score no score Shape OVAL Size 17mm Flavor Imprint Code V Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-171-40 1 in 1 CARTON 04/15/2019 1 40 in 1 BOTTLE; 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 04/15/2019 Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)