Label: PINK BISMUTH- bismuth subsalicylate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 70005-047-01 - Packager: We Care Distributor Inc.
- 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 October 25, 2016
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 15 mL)
- 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 and vomitting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrom, a rare but serious illness.
Allergy alert:Contains salicylates. Do not take if you are
- taking other salicylate products
- allergic to salicylates (including aspirin)
Ask a doctor before use if you have
- fever, mucus in the stool, a sodium-restricted diet, a magnesium restricted diet
Ask a doctor or pharmacist before use if you are
taking any drug for
- anticoagulation (thinning the blood), diabetes, gout, arthritis
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Directions
- Shake well before use
- Use pre-measured cup for accurate dosing. mL = mililiter
- Adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed
- Do not take more than 4 doses 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
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
PINK BISMUTH
bismuth subsalicylate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70005-047 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 262 mg in 15 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) D&C RED NO. 30 (UNII: 2S42T2808B) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SALICYLIC ACID (UNII: O414PZ4LPZ) SODIUM SALICYLATE (UNII: WIQ1H85SYP) SORBITOL (UNII: 506T60A25R) SODIUM BENZOATE (UNII: OJ245FE5EU) 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:70005-047-01 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/25/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 10/25/2016 Labeler - We Care Distributor Inc. (079832998) Establishment Name Address ID/FEI Business Operations PURINE PHARMA LLC 019950491 manufacture(70005-047)