FLANADOL PRONTO BISMUTH- bismuth subsalicylate liquid

FLANADOL PRONTO BISMUTH by

Drug Labeling and Warnings

FLANADOL PRONTO BISMUTH by is a Otc medication manufactured, distributed, or labeled by Jomex International Llc, Geri-Care Pharmaceuticals, Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each 15mL Tablespoonful = TBSP)

Bismuth Subsalicylate 262 mg

Purposes

Upset stomach reliever and antidiarrheal

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Uses   relieves   diarrhea   heartburn   indigestion   nausea   upset stomach

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.

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

Inactive ingredients benzoic acid, flavor, magnesium aluminium silicate, methylcellulose, purified water, red 22, red 28, saccharin sodium, salicylic acid, simethicone emulsion, sodium salicylate, sorbic acid, xanthan gum

Other information

 each 15 mL tablespoonful contains: sodium 6 mg

 salicylate 130 mg   protect from freezing   low sodium  sugar free

avoid excessive heat (over 104°F or 40°C)

visit www.info-xtra.com for health information

TAMPER EVIDENT: Do not use if imprinted neckband is missing or broken

QUESTIONS

Questions? 1-866-838-7456

SPL UNCLASSIFIED SECTION

Regular Strength

Manufactured for:
Jomex Pharmaceuticals, LLC
Fairfax Station, VA 22039 USA

Manufactured by:
GCP Laboratories, Inc.
Gulfport, MS 39501

www.jomexusa.com
www.flanadolusa.com

Packaging

INGREDIENTS AND APPEARANCE

FLANADOL PRONTO BISMUTH 
bismuth subsalicylate liquid

Product 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)