Indications and uses
Relieves: upset stomach indigestion diarrhea heartburn nausea
Estomaquil Polvo
- Manufacturer
- All Natural Dynamics
- Effective date
- 2022-06-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:49:59
Label at a glance#
ProductEstomaquil Polvo
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections
Dosage and administration
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.
Storage and handling
Avoid excessive heat Each pouch contains: sodium 223mg
Label contents#
Full prescribing information#
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
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking any drugs for:
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis.
OTC - WHEN USING SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1721449 | bismuth subsalicylate 262 MG Powder for Oral Suspension | PSN | 1 |
| 1721455 | Estomaquil 262 MG Powder for Oral Suspension | PSN | 1 |
| 1721455 | bismuth subsalicylate 262 MG Powder for Oral Suspension [Estomaquil] | SBD | 1 |
| 1721449 | bismuth subsalicylate 262 MG Powder for Oral Suspension | SCD | 1 |
| 1721455 | Estomaquil 262 MG Powder for Oral Suspension | SY | 1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51769-108-20 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-69db-198a-e063-dbdaa90aec3e | Estomaquil ® Polvo |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51769-108-20 | Estomaquil Polvo | 1 in 1 POUCH | POWDER | 1 | 1 | |
| 51769-108-20 | Estomaquil Polvo | 20 in 1 CARTON | POWDER | 20 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Estomaquil Polvo
- BISMUTH SUBSALICYLATE
- CALCIUM CARBONATE
- CITRIC ACID MONOHYDRATE
- MAGNESIUM HYDROXIDE
- SODIUM BICARBONATE
- TARTARIC ACID
- SALICYLIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51769-108 | 51769-108-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| MAGNESIUM HYDROXIDE | NBZ3QY004S | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| TARTARIC ACID | W4888I119H | IACT |
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e272c1cf-9795-0abd-e053-2995a90a2229 | e272c1cf-9793-0abd-e053-2995a90a2229 | 2022-06-27 | Warnings | e272c1cf-9795-0abd-e053-2995a90a2229 e272c1cf-9793-0abd-e053-2995a90a2229 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.