PINK BISMUTH

Manufacturer: Geri-Care Pharmaceuticals, Corp | GCP Laboratories
Effective date: 2020-03-31
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 23:38:14

Label at a glance#

ProductPINK BISMUTH

Active ingredientBISMUTH SUBSALICYLATE

Label structure8 sections

Indications and uses

relieves travelers’ diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea

Dosage and administration

shake well before using drink plenty of clear fluids to help prevent dehydration caused by diarrhea for accurate dosing, use dose cup adults and children 12 years and over take 2 TBSP every 1/2 hour to 1 hour as needed do not exceed 16 TBSP in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor

Storage and handling

each TBSP contains: sodium 6 mg. salicylate 130mg low sodium sugar free protect from freezing avoid excessive heat (over 104F or 40C) store at room temperature TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken. for health information visit www.info-xtra.com for health information

Contacts and useful links#

Websitewww.info-xtra.com

www.info-xtra.com

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL Tablespoon = TBSP)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purposes

OTC - PURPOSE SECTION

upset stomach reliever and antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

travelers’ diarrhea
diarrhea
upset stomach due to overindulgence in food and drink, including:
heartburn
indigestion
nausea

Warnings

WARNINGS SECTION

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 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
ringing in the ears or loss of hearing occurs
diarrhea lasts more than 2 days

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

shake well before using

drink plenty of clear fluids to help prevent dehydration caused by diarrhea
for accurate dosing, use dose cup

adults and children 12 years and over

take 2 TBSP every 1/2 hour to 1 hour as needed
do not exceed 16 TBSP in 24 hours
use until diarrhea stops but not more than 2 days

children under 12 years:ask a doctor

Other information

STORAGE AND HANDLING SECTION

each TBSP contains: sodium 6 mg. salicylate 130mg
low sodium
sugar free
protect from freezing
avoid excessive heat (over 104F or 40C)
store at room temperature
TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.
for health information visit www.info-xtra.com for health information

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, D and C red no. 22, D and C red no. 28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicyclic acid, simethicone emulsion, sodium salicylate, sorbic acid, xanthan gum

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GERICARE

NDC 57896-392-16

pink bismuth
regular strength
bismuth subsalicylate 262mg/ 15mL
upset stomach reliever/antidiarrheal
soothing relief for 5 symptoms
heartburn
indigestion
upset stomach
nausea
diarrhea
compare to the active ingredient of Pepto-Bismol
16 FL OZ (1 PT) (473 mL)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57896-392-08	ML - Milliliter	57896-392	0d1d551f-aa40-4bed-a505-1be757c816dc	1	2018-02-20
57896-392-16	ML - Milliliter	57896-392	09dadf6e-45f7-46d1-a7b5-f416c0545eb0	1	2018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	1
BISMUTH SUBSALICYLATE	ACTIVE MOIETY	62TEY51RR1	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	1
D&C RED NO. 22	INACTIVE INGREDIENT	1678RKX8RT	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	1
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	1
METHYLCELLULOSE (100 CPS)	INACTIVE INGREDIENT	4GFU244C4J	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	1
SODIUM SALICYLATE	INACTIVE INGREDIENT	WIQ1H85SYP	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

PINK BISMUTH
bismuth subsalicylate
BENZOIC ACID
D&C RED NO. 22
D&C RED NO. 28
MAGNESIUM ALUMINUM SILICATE
METHYLCELLULOSE (100 CPS)
WATER
SACCHARIN SODIUM
SACCHARIN
SALICYLIC ACID
DIMETHICONE
SODIUM SALICYLATE
SORBIC ACID
XANTHAN GUM
METHYL SALICYLATE
BISMUTH CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57896-392	57896-392-08, 57896-392-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZOIC ACID	8SKN0B0MIM	IACT
D&C RED NO. 22	1678RKX8RT	IACT
D&C RED NO. 28	767IP0Y5NH	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
METHYLCELLULOSE (100 CPS)	4GFU244C4J	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SALICYLIC ACID	O414PZ4LPZ	IACT
DIMETHICONE	92RU3N3Y1O	IACT
SODIUM SALICYLATE	WIQ1H85SYP	IACT
SORBIC ACID	X045WJ989B	IACT
XANTHAN GUM	TTV12P4NEE	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
BISMUTH SUBSALICYLATE	62TEY51RR1	ACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 146 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
D&C RED NO. 22	D&C RED NO. 22	1678RKX8RT	TABLET, DELAYED RELEASE / ORAL	0.38 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SUSPENSION/ DROPS / ORAL	4.15 mg/2.5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	AEROSOL, FOAM / TOPICAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CONCENTRATE / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 23 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 23 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	CREAM / TOPICAL	3 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
D&C RED NO. 22	D&C RED NO. 22	1678RKX8RT	CAPSULE, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	LOTION / TOPICAL		4 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	SOLUTION / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	TABLET / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	TABLET, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	DOUCHE / VAGINAL	0.05 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
D&C RED NO. 22	D&C RED NO. 22	1678RKX8RT	CAPSULE / ORAL	0.02 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	INJECTION, SOLUTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 17 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SHAMPOO / TOPICAL	1.25 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
D&C RED NO. 22	D&C RED NO. 22	1678RKX8RT	SUSPENSION / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	LIQUID / ORAL	82 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, DELAYED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	SUSPENSION / ORAL		40 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	LIQUID / ORAL	2 mg/1ml		Exact identifier — unii candidate 23 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SYRUP / ORAL		20 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET / SUBLINGUAL	0.16 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	INJECTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SYRUP / ORAL	100 mg/1ml		Exact identifier — unii candidate 17 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, CHEWABLE / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SUPPOSITORY / VAGINAL	2 mg		Exact identifier — unii candidate 23 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	CREAM / TOPICAL		46 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, FILM COATED / ORAL	0.08 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	TABLET / ORAL	60 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a22a6ab9-3e7c-f7f5-e053-2995a90af1c6			c4a92dca-331f-47b1-bf4d-117c73addc33	2020-03-31	Warnings	Exact identifier spl id: a22a6ab9-3e7c-f7f5-e053-2995a90af1c6 spl set id: c4a92dca-331f-47b1-bf4d-117c73addc33

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.