1. Home
  2. Labeler Index
  3. Promex Llc
  4. 58988-1080
  5. Label Information: Estomaquil Polvo

FDA Label for Estomaquil Polvo

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. REYE`S SYNDROME
    6. ALLERGY ALERT
    7. OTC - DO NOT USE
    8. ASK A DOCTOR BEFORE USE IF YOU HAVE
    9. OTC - ASK DOCTOR/PHARMACIST
    10. OTC - WHEN USING
    11. STOP USE AND ASK A DOCTOR IF
    12. OTC - PREGNANCY OR BREAST FEEDING
    13. OTC - KEEP OUT OF REACH OF CHILDREN
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. PRINCIPAL DISPLAY PANEL - 10 PACKET CARTON

Estomaquil Polvo Product Label

The following document was submitted to the FDA by the labeler of this product Promex Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



DRUG FACTS


Active Ingredient



Bismuth Subsalicylate: Each pouch contains 262 mg


Purpose



Upset Stomach reliever / Antidiarrheal


Uses



Relieves:

  • upset stomach
  • indigestion
  • diarrhea
  • heartburn
  • nausea

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



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



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

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis.

Otc - When Using



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



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


Otc - Keep Out Of Reach Of Children



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:

* Please review the disclaimer below.