FLANADOL PRONTO BISMUTH- bismuth subsalicylate liquid 
Jomex International Llc

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.

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FLANADOL PRONTO BISMUTH

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

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

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.

Directions  • shake well before use

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? 1-866-838-7456

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

pronto1

Spanish

FLANADOL PRONTO BISMUTH 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69458-713
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69458-713-08355 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33504/15/2016
Labeler - Jomex International Llc (833120707)
Establishment
NameAddressID/FEIBusiness Operations
Geri-Care Pharmaceuticals, Corp611196254manufacture(69458-713)

Revised: 7/2016
Document Id: 3cad412b-ffdf-4761-b750-0f1485f8a372
Set id: d0053c7f-1448-40f6-a7e7-279d2dff926a
Version: 1
Effective Time: 20160701
 
Jomex International Llc