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| Product NDC Code | 0363-0736 | ||||
|---|---|---|---|---|---|
| Drug Name | Soothe |
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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 | M008 | ||||
| Labeler Name | Walgreens | ||||
| Packages |
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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 1/2 or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea 30 mL (1 dose) every 1/2 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 travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas 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.Soothe Bismuth subsalicylate BISMUTH SUBSALICYLATE BISMUTH CATION SALICYLIC ACID BENZOIC ACID D&C RED NO. 22 D&C RED NO. 28 GLYCERIN WATER XANTHAN GUM SUCRALOSE
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 Compare to the active ingredient Pepto-Bismol®†† Soothe BISMUTH SUBSALICYLATE 525 mg / UPSET STOMACH RELIEVER / ANTIDIARRHEAL Sugar Free Alcohol Free Relieves heartburn, indigestion, nausea, upset stomach & diarrhea Cherry Flavor FL OZ (mL) ††This product is not manufactured or distributed by The Procter & Gamble Company, Pepto-Bismol® is a registered trademark of The Procter & Gamble Company. TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015
Package Label WALGREENS Soothe Bismuth Subsalicylate 525 mg
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 childen. In case of overdose, get medical help or contact a Posion 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 or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
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 : sodium11 mg each 30 mL contains : salicylate 206 mg low sodium keep tightly closed protect from freezing avoid excessive heat (over 104ºF or 40ºC)
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 childen. In case of overdose, get medical help or contact a Posion 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