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| Product NDC Code | 66715-6855 | ||||
|---|---|---|---|---|---|
| Drug Name | Stomach lil drug store products |
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| Type | Brand | ||||
| Pharm Class | Bismuth [CS], Bismuth [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 308762 | ||||
| Application Number | M001 | ||||
| Labeler Name | Lil' Drug Store Products, Inc | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 30 mL dose) Bismuth subsalicylate 525 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 hour or 60 mL (2 doses) every hour as needed for diarrhea/travelers' diarrhea 30 mL ( 1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzoic acid, D&C red #22, D&C red #28, flavor, glycerin, purified water, sucralose, xanthan gum
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses relieves diarrhea travelers' diarrhea upset stomach due to overindulgence in food and drink, including heartburn gas indigestion nausea fullness belching
Purpose
Information about the drug product’s indications for use.Purpose Upset stomach reliever/Antidiarrheal
Spl product data elements
Usually a list of ingredients in a drug product.Stomach Lil Drug Store Products Bismuth Subsalicylate BENZOIC ACID D&C RED NO. 22 D&C RED NO. 28 GLYCERIN WATER SUCRALOSE XANTHAN GUM BISMUTH SUBSALICYLATE BISMUTH CATION Stomach Circle K Bismuth Subsalicylate BENZOIC ACID D&C RED NO. 22 D&C RED NO. 28 GLYCERIN WATER SUCRALOSE XANTHAN GUM BISMUTH SUBSALICYLATE BISMUTH CATION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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 • Nausea • Heartburn • Indigestion • Upset Stomach • Diarrhea 8 FL OZ (237 mL) Lil' Drug Store ® PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
Circle K™ Soothe Upset Stomach -PDP/Package RELIEF OF NAUSEA, HEARTBURN, INDIGESTION, UPSET STOMACH, DIARRHEA Compare to the active ingredient in Pepto-Bismol ® * [Circle K logo] soothe upset stomach Bismuth Subsalicylate 525 mg Upset Stomach Reliever/Antidiarrheal 8 fl oz (237 mL) PDP/Package
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have fever mucus in the stool
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking any drug for diabetes gout arthritis anticoagulation (thinning the blood)
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have an ulcer a bleeding problem bloody or black stool
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call toll free 1-877-507-6516 (M-F 8AM-4:30PM CST)
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information each 30 mL contains: potassium 8 mg, sodium 6 mg each 30 mL contains: salicylate 206 mg low sodium keep tightly closed protect from freezing avoid excessive heat (over 104°F or 40°C)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 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)
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API