Label: FLANADOL PRONTO BISMUTH- bismuth subsalicylate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 69458-713-08 - Packager: Jomex International Llc
- 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 July 1, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each 15mL Tablespoonful = TBSP)
- Purposes
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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 behaviour 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 • diarrhea lasts more than 2 days • ringing in the ears or loss of hearing occurs
If pregnant or breast feeding, ask a health professional before use.
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DOSAGE & ADMINISTRATION
Directions • shake well before use
- use dose cup or tablespoon (TBSP)
- adults and children 12 years and over:
1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour as needed - do not exceed 8 doses (240 mL or 16 TBSP) 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
- INACTIVE INGREDIENT
- Other information
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
FLANADOL PRONTO BISMUTH
bismuth subsalicylate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69458-713 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 in 15 mL Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J) WATER (UNII: 059QF0KO0R) D&C RED NO. 22 (UNII: 1678RKX8RT) D&C RED NO. 28 (UNII: 767IP0Y5NH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SALICYLIC ACID (UNII: O414PZ4LPZ) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM SALICYLATE (UNII: WIQ1H85SYP) SORBIC ACID (UNII: X045WJ989B) XANTHAN GUM (UNII: TTV12P4NEE) METHYL SALICYLATE (UNII: LAV5U5022Y) Product Characteristics Color pink Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69458-713-08 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 04/15/2016 Labeler - Jomex International Llc (833120707) Establishment Name Address ID/FEI Business Operations Geri-Care Pharmaceuticals, Corp 611196254 manufacture(69458-713)
