ESTOMAQUIL POLVO- bismuth subsalicylate powder

Estomaquil Polvo by

Drug Labeling and Warnings

Estomaquil Polvo by is a Otc medication manufactured, distributed, or labeled by ProMex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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: 58988-1080
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TARTARIC ACID (UNII: W4888I119H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58988-1080-1	10 in 1 CARTON	01/02/2004
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 58988-1080-2	20 in 1 CARTON	01/02/2004
2		1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 58988-1080-3	50 in 1 CARTON	01/02/2004
3		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part335	01/02/2004

Labeler - ProMex LLC (789974388)