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NDC 51769-0108-20 Estomaquil Polvo 262 mg/1 Details

Estomaquil Polvo 262 mg/1

Estomaquil Polvo is a ORAL POWDER in the HUMAN OTC DRUG category. It is labeled and distributed by All Natural Dynamics. 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: 51769-0108-20
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	51769-0108
Product ID	51769-108_e272c1cf-9795-0abd-e053-2995a90a2229
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	Estomaquil Polvo
Proprietary Name Suffix	n/a
Non-Proprietary Name	BISMUTH SUBSALICYLATE
Product Type	HUMAN OTC DRUG
Dosage Form	POWDER
Route	ORAL
Active Ingredient Strength	262
Active Ingredient Units	mg/1
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	All Natural Dynamics
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part335
Listing Certified Through	2023-12-31

Package

Package Images

NDC 51769-0108-20 (51769010820)

Pricing Information	N/A
NDC Package Code	51769-108-20
Billing NDC	51769010820
Package	20 POUCH in 1 CARTON (51769-108-20) / 1 POWDER in 1 POUCH
Marketing Start Date	2022-06-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e272c1cf-9793-0abd-e053-2995a90a2229 Details

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

Bismuth Subsalicylate: Each pouch contains 262 mg

Purpose

Upset Stomach reliever / Antidiarrheal

Uses

Relieves:

upset stomach
indigestion
diarrhea
heartburn
nausea

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 or vomiting occur, consult a doctor 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 salicylate (including aspirin)
taking other salicylate products

Do not use if you have

an ulcer
bleeding problem
bloody or black stool.

Ask a doctor before use if you have

fever
mucus in stool.

Ask a doctor or pharmacist before use if you are taking any drugs 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 ears or loss of hearing occurs
if diarrhea lasts more than 2 days.

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

Keep out of the reach of children. In case of overdose, seek professional help or contact a poison control center immediately.

Directions

Adults & Children 12 yrs or older: Dissolve 2 pouches in 1/2 glass of water. Repeat every 1/2 to 1 hour as needed, to a maximum of 8 doses in a 24-hour period.

use until diarrhea stops, but not more than 2 days, If symptoms persist, consult a doctor.
Drink plenty of clear fluids to help prevent dehydration which may accompany diarrhea.
Children under 12 yrs ask a doctor.

Other Information

Avoid excessive heat
Each pouch contains: sodium 223mg

Inactive Ingredients

calcium carbonate, citric acid, magnesium hydroxide, sodium bicarbonate, tartaric acid

PRINCIPAL DISPLAY PANEL - 10 Packet Carton

ESTOMAQUIL®

Relief for:

Nausea
Heartburn
Diarrhea
Fullness

Maximum Strength

10 Packets

INGREDIENTS AND APPEARANCE

ESTOMAQUIL POLVO

bismuth subsalicylate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51769-108
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TARTARIC ACID (UNII: W4888I119H)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51769-108-20	20 in 1 CARTON	06/27/2022
1		1 in 1 POUCH; 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	06/27/2022

Labeler - All Natural Dynamics (962732892)

Registrant - All Natural Dynamics (962732892)

Revised: 6/2022

Document Id: e272c1cf-9795-0abd-e053-2995a90a2229

Set id: e272c1cf-9793-0abd-e053-2995a90a2229

Version: 1

Effective Time: 20220627