STOMACH LIL DRUG STORE PRODUCTS- bismuth subsalicylate liquid

Stomach by

Drug Labeling and Warnings

Stomach by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever/Antidiarrheal

Uses

relieves

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

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 and vomiting occur, consult a doctor because 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 salicylates (including aspirin)
• taking other salicylate products

Do not use if you have

• an ulcer
• a bleeding problem
• bloody or black stool

Ask a doctor before use if you have

• fever
• mucus in the stool

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

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

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 or last more than 2 days
• ringing in the ears or loss of hearing occurs
• diarrhea lasts more than 2 days

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• mL = milliliter
• shake well before using
• measure only with dosing cup provided. Do not use any other dosing device.
• keep dosing cup with product
• adults and children 12 years and over:
• 30 mL (1 dose) every ½ to 1 hour as needed
• do not exceed 8 doses (240 mL) in 24 hours
• use until diarrhea stops but not more than 2 days
• children under 12 years of age: ask a doctor
• drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

• each 30 mL contains: sodium 6 mg
• each 30 mL contains: salicylate 243 mg
• low sodium
• keep tightly closed
• protect from freezing
• avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

benzoic acid, D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid

Questions or comments?

Call toll free 1-877-507-6516 (M-F 8AM-4:30PM CST)

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

QUALITY
GUARANTEED

Compare to the Active
Ingredient in Pepto-Bismol®*

Stomach

Bismuth Subsalicylate 525 mg
Upset Stomach Reliever/Antidiarrheal

Relieves
Diarrhea Upset Stomach
Heartburn Indigestion Nausea

8 FL OZ
(237 mL)

Lil'
Drug Store®

INGREDIENTS AND APPEARANCE

STOMACH   LIL DRUG STORE PRODUCTS
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-6855
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bismuth Subsalicylate (UNII: 62TEY51RR1) (Bismuth Cation - UNII:ZS9CD1I8YE, Salicylic Acid - UNII:O414PZ4LPZ)	Bismuth Subsalicylate	525 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Benzoic acid (UNII: 8SKN0B0MIM)
D&C red NO. 22 (UNII: 1678RKX8RT)
D&C red NO. 28 (UNII: 767IP0Y5NH)
Magnesium aluminum silicate (UNII: 6M3P64V0NC)
Water (UNII: 059QF0KO0R)
Saccharin sodium (UNII: SB8ZUX40TY)
salicylic acid (UNII: O414PZ4LPZ)
sodium salicylate (UNII: WIQ1H85SYP)
sorbic acid (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-6855-4	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part335	12/01/2014

Labeler - Lil' Drug Store Products, Inc (093103646)