FLANADOL PRONTO BISMUTH- bismuth subsalicylate liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
Jomex International Llc
INN (International Name):
BISMUTH SUBSALICYLATE
Composition:
BISMUTH SUBSALICYLATE 262 mg in 15 mL
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Upset stomach reliever and antidiarrheal Uses    relieves  • diarrhea  • heartburn  • indigestion  • nausea  • upset stomach
Authorization status:
OTC monograph final
Authorization number:
69458-713-08

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

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.

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 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.flanadolus a.com

Packaging

FLANADOL PRONTO BISMUTH

bismuth subsalicylate liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 458 -713

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BISMUTH SUBSALICYLATE (UNII: 6 2TEY51RR1) (SALICYLIC ACID -

UNII:O414PZ4LPZ)

BISMUTH

SUBSALICYLATE

26 2 mg

in 15 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Jomex International Llc

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

MAGNESIUM ALUMINUM SILICATE (UNII: 6 M3P6 4V0 NC)

METHYLCELLULO SE ( 10 0 CPS) (UNII: 4GFU244C4J)

WATER (UNII: 0 59 QF0 KO0 R)

D&C RED NO . 2 2 (UNII: 16 78 RKX8 RT)

D&C RED NO . 2 8 (UNII: 76 7IP0 Y5NH)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SALICYLIC ACID (UNII: O414PZ4LPZ)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

SO DIUM SALICYLATE (UNII: WIQ1H8 5SYP)

SO RBIC ACID (UNII: X0 45WJ9 8 9 B)

XANTHAN GUM (UNII: TTV12P4NEE)

METHYL SALICYLATE (UNII: LAV5U50 22Y)

Product Characteristics

Color

pink

S core

S hap e

S iz e

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 458 -713-0 8

355 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/15/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt335

0 4/15/20 16

Labeler -

Jomex International Llc (833120707)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Geri-Care Pharmaceuticals, Co rp

6 1119 6 254

ma nufa c ture (6 9 458 -713)

Revised: 7/2016

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