Search by Drug Name or NDC

NDC 57896-0396-12 GERI-PECTATE PEPPERMINT FLAVOR 262 mg/15mL Details

GERI-PECTATE PEPPERMINT FLAVOR 262 mg/15mL

GERI-PECTATE PEPPERMINT FLAVOR is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Geri-Care Pharmaceuticals, Corp. The primary component is BISMUTH SUBSALICYLATE.

MedlinePlus Drug Summary

Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.

Related Packages: 57896-0396-12
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	57896-0396
Product ID	57896-396_7e066c73-63fe-1c6e-e053-2a91aa0afb45
Associated GPIs	47300010001805
GCN Sequence Number	002858
GCN Sequence Number Description	bismuth subsalicylate ORAL SUSP 262MG/15ML ORAL
HIC3	D6D
HIC3 Description	ANTIDIARRHEALS
GCN	26970
HICL Sequence Number	001246
HICL Sequence Number Description	BISMUTH SUBSALICYLATE
Brand/Generic	Generic
Proprietary Name	GERI-PECTATE PEPPERMINT FLAVOR
Proprietary Name Suffix	n/a
Non-Proprietary Name	bismuth subsalicylate
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	262
Active Ingredient Units	mg/15mL
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	Geri-Care Pharmaceuticals, Corp
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part335
Listing Certified Through	2022-12-31

Package

Package Images

NDC 57896-0396-12 (57896039612)

Pricing Information	N/A
NDC Package Code	57896-396-12
Billing NDC	57896039612
Package	355 mL in 1 BOTTLE (57896-396-12)
Marketing Start Date	2011-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0ac6008f-7547-4ea3-831b-067d1d282938 Details

Active ingredient (in each 15 mL tablespoon=Tbsp)

Bismuth subsalicylate 262 mg

Purposes

antidiarrheal and upset stomach reliever

Uses

relieves diarrhea

relieves upset stomach and nausea associated with it

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 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.

Keep out of reach of children. In case of overdose, get medical help or contact a

Poison Control Center right away.

Directions

shake well before using

drink plenty of clear fluids to help prevent dehydration caused by diarrhea

adults and children 12 years and over

take 30 mL= 2 tablespoonfuls (Tbsp)
repeat dose every 1/2 hour to 1 hour as needed
do not exceed 8 doses (16 Tbsp or 240 mL) in 24 hours
use until diarrhea stops but not more than 2 days

children under 12 years:

ask a doctor

Other information

each 15 mL tablespoon contains: salicylate 130mg, sodium 10 mg
protect from freezing
avoid excessive heat (over 104F or 40C)
TAMPER-EVIDENT: Do not use this product if foil seal under cap is missing or broken.
visit www.info-xtra.com for health information

Inactive ingredients

caramel, carboxymethylcellulose sodium, FD and C red no. 40, flavor, microcrystalline cellulose, purified water, sodium salicylate, sorbic acid, sucrose, titanium dioxide, xanthan gum

package Label

INGREDIENTS AND APPEARANCE

GERI-PECTATE PEPPERMINT FLAVOR

bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57896-396
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	262 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
CARAMEL (UNII: T9D99G2B1R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
PEPPERMINT OIL (UNII: AV092KU4JH)

Product Characteristics
Color	red (brownish-red)	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57896-396-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	01/01/2000

Labeler - Geri-Care Pharmaceuticals, Corp (611196254)

Registrant - GCP Laboratories (965480861)

Name	Address	ID/FEI	Business Operations
Establishment
GCP LABORATORIES		965480861	manufacture(57896-396)

Revised: 12/2018

Document Id: 7e066c73-63fe-1c6e-e053-2a91aa0afb45

Set id: 0ac6008f-7547-4ea3-831b-067d1d282938

Version: 2

Effective Time: 20181227