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| Product NDC Code | 36800-661 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Topcare regular strength |
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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 | SUSPENSION | ||||||
| RxCUI drug identifier | 308762 | ||||||
| Application Number | M008 | ||||||
| Labeler Name | TOPCO ASSOCIATES LLC | ||||||
| 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 ▪ shake well before use ▪ Only use dose cup provided ▪ adults and children 12 years and over: (30 mL) 1 dose every 1/2 or 60 mL every 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: 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 carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, 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 ▪ belching ▪ fullness
Purpose
Information about the drug product’s indications for use.Purposes Upset stomach reliever and antidiarrheal
Spl product data elements
Usually a list of ingredients in a drug product.TopCare Regular Strength Bismuth subsalicylate BISMUTH SUBSALICYLATE BISMUTH CATION SALICYLIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED D&C RED NO. 22 D&C RED NO. 28 MICROCRYSTALLINE CELLULOSE POTASSIUM HYDROXIDE POTASSIUM SORBATE WATER SALICYLIC ACID DIMETHICONE SODIUM BENZOATE SUCRALOSE XANTHAN GUM viscous
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 TopCare ® health ™ *Compare to the Active Ingredient Pepto-Bismol® Regular Strength REGULAR STRENGTH Pink Bismuth Bismuth Subsalicylate 525 mg per 30 mL Upset Stomach Reliever/Antidiarrheal Relieves: • Nausea • Heartburn • Indigestion • Upset Stomach • Diarrhea Cherry Flavor Naturally and Artificially Flavored DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 TOPCO RARA1217 QUESTIONS? 1-888-423-0139 [email protected] , www.topcarebrand.com *This product is not manufactured or distributed by Procter & Gamble, distributor Pepto-Bismol ® Regular Strength. Package Label 473 mL Package Label 236 mL Topcare Regular Strength Pink Bismuth Cherry Flavor 236 mL Topcare Regular Strength Pink Bismuth 473 mL
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 ▪ anticoagulation (thinning the blood) ▪ diabetes ▪ gout ▪ arthritis
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 at (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? 1-866-467-2748 DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN.
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: sodium 10 mg ▪ salicylate 261 mg ▪ low sodium ▪ sugar free ▪ store at room temperature ▪ 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 or 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 ▪ 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 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 at (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