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NDC 41163-0058-49 Equaline Stomach Relief 262 mg/1 Details

Equaline Stomach Relief 262 mg/1

Equaline Stomach Relief is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Supervalu Inc.. 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: 41163-0058-49
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	41163-0058
Product ID	41163-058_8e9dac6c-a287-46da-97fa-a913c29454d1
Associated GPIs
GCN Sequence Number	002860
GCN Sequence Number Description	bismuth subsalicylate TAB CHEW 262 MG ORAL
HIC3	D6D
HIC3 Description	ANTIDIARRHEALS
GCN	08420
HICL Sequence Number	001246
HICL Sequence Number Description	BISMUTH SUBSALICYLATE
Brand/Generic	Generic
Proprietary Name	Equaline Stomach Relief
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	Supervalu Inc.
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 41163-0058-49 (41163005849)

Pricing Information	N/A
NDC Package Code	41163-058-49
Billing NDC	41163005849
Package	5 BLISTER PACK in 1 BOX (41163-058-49) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	2022-01-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5dae8bbe-219b-4aa1-bf7f-6471fa2856d9 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
use until diarrhea stops but not more than 2 days
children under 12 years: ask a doctor
drink plenty of fluids to help prevent dehydration caused 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 on open.

INACTIVE INGREDIENTS

calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium

PRINCIPAL DISPLAY PANEL

NDC 41163-058-49

compare to Pepto-Bismol® Chewable Tablets active ingredient*

EQUALINE

chewable

stomach relief

tablets

bismuth subsalicylate 262 mg

(upset stomach reliever / anti-diarrheal)

relieves:

heartburn
indigestion
nausea
upset stomach
diarrhea

GLUTEN FREE

30 chewable tablets

INGREDIENTS AND APPEARANCE

EQUALINE STOMACH RELIEF

bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-058
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)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41163-058-49	5 in 1 BOX	01/05/2022
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	01/05/2022

Labeler - Supervalu Inc. (006961411)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	MANUFACTURE(41163-058)

Revised: 11/2022

Document Id: 8e9dac6c-a287-46da-97fa-a913c29454d1

Set id: 5dae8bbe-219b-4aa1-bf7f-6471fa2856d9

Version: 2

Effective Time: 20221121