Estomaquil®

Estomaquil®
SPL v4
SPL
SPL Set ID cf94c99a-c489-45ec-bb13-3e6959e377de
Route
ORAL
Published
Effective Date 2023-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Calcium Carbonate Citric Acid Monohydrate Magnesium Hydroxide Sodium Bicarbonate Tartaric Acid Maltodextrin Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-01-02

Description

Drug Facts

Purpose

Upset stomach reliever / Antidiarrheal


Medication Information

Purpose

Upset stomach reliever / Antidiarrheal

Description

Drug Facts

Uses

relieves:

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Section 50568-5

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

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis
Section 53414-9

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

Directions
  • 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
Allergy Alert

Contains salicylate. Do not take if you are:

  • allergic to salicylate (including aspirin)
  • taking other salicylate products
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 because these symptoms could be an early sign of Reye`s syndrome, a rare but serious illness

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

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

Do Not Use If You Have
  • an ulcer
  • a bleeding problem
Stop Use and Ask A Doctor If
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
Active Ingredient (in Each Pouch)

Bismuth Subsalicylate 262 mg

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
Principal Display Panel 3.0 G Pouch Carton

ESTOMAQUIL®

Bismuth Subsalicylate 262 mg

Relief for:

  • Nausea
  • Heartburn
  • Diarrhea
  • Fullness

Maximum Strength

10 Pouches

0.1 oz (3.0 g) Each


Structured Label Content

Uses

relieves:

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Section 50568-5 (50568-5)

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

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis
Section 53414-9 (53414-9)

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

Purpose

Upset stomach reliever / Antidiarrheal

Directions
  • 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
Allergy Alert (Allergy alert)

Contains salicylate. Do not take if you are:

  • allergic to salicylate (including aspirin)
  • taking other salicylate products
Reye`s Syndrome (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 because these symptoms could be an early sign of Reye`s syndrome, a rare but serious illness

Other Information (Other information)
  • each pouch contains: calcium 210 mg, magnesium 190 mg, sodium 206 mg
  • avoid excessive heat
Inactive Ingredients (Inactive ingredients)

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

Do Not Use If You Have (Do not use if you have)
  • an ulcer
  • a bleeding problem
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
Active Ingredient (in Each Pouch) (Active ingredient (in each pouch))

Bismuth Subsalicylate 262 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • mucus in the stool
Principal Display Panel 3.0 G Pouch Carton (PRINCIPAL DISPLAY PANEL - 3.0 g Pouch Carton)

ESTOMAQUIL®

Bismuth Subsalicylate 262 mg

Relief for:

  • Nausea
  • Heartburn
  • Diarrhea
  • Fullness

Maximum Strength

10 Pouches

0.1 oz (3.0 g) Each


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)