Estomaquil Polvo

Label at a glance#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each pouch)

OTC - ACTIVE INGREDIENT SECTION

Bismuth Subsalicylate 262 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever / Antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves:

• travelers' diarrhea
• diarrhea
• upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness

Warnings

WARNINGS SECTION

Reye`s syndrome

SPL UNCLASSIFIED SECTION

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 because these symptoms could be an early sign of Reye`s syndrome, a rare but serious illness

Allergy alert

SPL UNCLASSIFIED SECTION

Contains salicylate. Do not take if you are:

• allergic to salicylate (including aspirin)
• taking other salicylate products

Do not use if you have

OTC - DO NOT USE SECTION

• an ulcer
• a bleeding problem

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• fever
• mucus in the stool

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any drug 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

OTC - STOP USE SECTION

• symptoms get worse
• ringing in the ears or loss of hearing occurs
• 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

DOSAGE & ADMINISTRATION SECTION

• Adults & Children 12 yrs and older: Dissolve 2 pouches (1 dose) 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

STORAGE AND HANDLING SECTION

• each pouch contains: calcium 210 mg, magnesium 190 mg, sodium 206 mg
• avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, calcium carbonate, magnesium hydroxide, maltodextrin, silicon dioxide, sodium bicarbonate, tartaric acid

SPL UNCLASSIFIED SECTION

Distributed By:
PRO-MEX^®
P.O. Box 63-0716
Miami, FL. 33163

PRINCIPAL DISPLAY PANEL - 3.0 g Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ESTOMAQUIL^®

Bismuth Subsalicylate 262 mg

Relief for:

• Nausea
• Heartburn
• Diarrhea
• Fullness

Maximum Strength

10 Pouches
0.1 oz (3.0 g) Each

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

• Estomaquil Polvo
• BISMUTH SUBSALICYLATE
• SALICYLIC ACID
• CALCIUM CARBONATE
• CITRIC ACID MONOHYDRATE
• MAGNESIUM HYDROXIDE
• SODIUM BICARBONATE
• TARTARIC ACID
• MALTODEXTRIN
• SILICON DIOXIDE

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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Inactive ingredient links page 1 of 4 · 184 matching rows.

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

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