FDA Label for Stomach Lil Drug Store Products
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH 30 ML)
- PURPOSE
- USES
- REYE'S SYNDROME
- ALLERGY ALERT
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 237 ML BOTTLE LABEL
Stomach Lil Drug Store Products Product Label
The following document was submitted to the FDA by the labeler of this product Lil' Drug Store Products, Inc. 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 (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
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
Otc - Do Not Use
Do not use if you have
- an ulcer
- a bleeding problem
- bloody or black stool
Otc - Ask Doctor
Ask a doctor before use if you have
- fever
- mucus in the stool
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any drug for
- diabetes
- gout
- arthritis
- anticoagulation (thinning of the blood)
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 or last more than 2 days
- ringing in the ears or loss of hearing occurs
- 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 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 10 mg
- each 30 mL contains: salicylate 243 mg
- sugar free
- 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®
* Please review the disclaimer below.