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| Product NDC Code | 17714-045 | ||||
|---|---|---|---|---|---|
| Drug Name | Pepto relief |
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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 | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 308761 | ||||
| Application Number | part335 | ||||
| Labeler Name | Advance Pharmaceutical 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 tablet) Bismuth subsalicylate 262 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 drink plenty of clear fluids to help prevent dehydration caused by diarrhea repeat dosage every 1/2 to 1 hour as needed do not take more than 8 doses in 24 hours use until diarrhea stops but not more than 2 days adults and children 12 years and over: 2 tablets children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT calcium carbonate, D&C red # 27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol
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 Controls diarrhea Relieves upset stomach due to overindulgence in food or drink
Purpose
Information about the drug product’s indications for use.Purpose Anti-diarrheal/Upset stomach reliever
Spl product data elements
Usually a list of ingredients in a drug product.Pepto Relief Bismuth subsalicylate CALCIUM CARBONATE D&C RED NO. 27 DEXTROSE CHERRY MAGNESIUM STEARATE MALTODEXTRIN SILICON DIOXIDE SORBITOL BISMUTH SUBSALICYLATE BISMUTH CATION light AP;045
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.Package Label NDC: 17714-045-30 – 30 CHEWABLE TABLETS c247abd4-figure-01 c247abd4-figure-02
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 .
Other Information Each tablet contains: calcium 77 mg, salicylate 102 mg store at 15°-30°C (59°-86°F) protect from moisture
Questions or Comments TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Call 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday
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.
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: Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products Do not use If you have bloody or black stool If you have an ulcer or bleeding problem 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 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.
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