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NDC 37808-0587-77 HEB Stomach Relief Cherry 262 mg/1 Details

HEB Stomach Relief Cherry 262 mg/1

HEB Stomach Relief Cherry is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by H E B. 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: 37808-0587-77
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	37808-0587
Product ID	37808-587_98c7a61e-27d3-4a57-8d18-aeee3f4391b5
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	HEB Stomach Relief Cherry
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bismuth subsalicylate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	262
Active Ingredient Units	mg/1
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	H E B
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part335
Listing Certified Through	2024-12-31

Package

Package Images

NDC 37808-0587-77 (37808058777)

Pricing Information	N/A
NDC Package Code	37808-587-77
Billing NDC	37808058777
Package	5 BLISTER PACK in 1 BOX (37808-587-77) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	2021-09-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0277d4d7-c254-4eea-8f2e-4936d015a80f Details

ACTIVE INGREDIENT(in each tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

PURPOSE

Upset stomach reliever and anti-diarrheal

USE(S)

relieves:

diarrhea
heartburn
indigestion
nausea
upset stomach associated with these symptoms

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

bloody or black stool
an ulcer
a bleeding problem

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 of 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 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 immediately.

DIRECTIONS

chew or dissolve in mouth
adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
do not take more than 8 doses (16 tablets) in 24 hours
children under 12 years: ask a doctor
drink plenty of clear fluids to help prevent dehydration caused by diarrhea

OTHER INFORMATION

each tablet contains:
sodium less than 1 mg
salicylate 102 mg
very low sodium
avoid excessive heat (over 104oF or 40oC)
TAMPER EVIDENT: Do not use if individual compartments are torn or open

INACTIVE INGREDIENTS

adipic acid, calcium carbonate, D&C red 27 aluminum lake, FD&C red 40 aluminum lake, flavors, magnesium stearate, mannitol, povidone, pregelatinized starch, saccharin sodium

PRINCIPAL DISPLAY PANEL

Compate to Pepto-Bismol® Chewable active ingredient*

NDC 37808-587-77

HEB

Stomach Relief

Bismuth Subsalicylate, 262 mg

Upset Stomach Reliever/Antidiarrheal

Multi-Symptom Relief

Relief of:

Nausea
Heartburn
Indigestion
Upset stomach
Diarrhea

Cherry Flavor

30 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

HEB STOMACH RELIEF CHERRY

bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37808-587
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STARCH, CORN (UNII: O8232NY3SJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ADIPIC ACID (UNII: 76A0JE0FKJ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY	Imprint Code	G122
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:37808-587-77	5 in 1 BOX	09/14/2021
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part335	09/14/2021

Labeler - H E B (007924756)

Revised: 11/2022

Document Id: 98c7a61e-27d3-4a57-8d18-aeee3f4391b5

Set id: 0277d4d7-c254-4eea-8f2e-4936d015a80f

Version: 2

Effective Time: 20221122