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Drug Facts
Premier Value Diarrhea Relief Suspension
FDA Label NDC 68016-317
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Premier Value Diarrhea Relief (NDC 68016-317). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (per 15 ml), purposes, uses, reye's syndrome:, allergy alert: contains salicylate. do not take if you are, otc - do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (Per 15 Ml)
Bismuth Subsalicylate 262 mg
Purposes
Anti-diarrheal/Upset stomach reliever
Uses
relieves
▪ traveler’s diarrhea▪ diarrhea▪ upset stomach due to overindulgence in food and drink▪ heartburn▪ indigestion▪ nausea▪ gas
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
▪ a sodium-restricted diet▪ 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 the blood)
Otc - When Using
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur
Otc - Stop Use
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
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 at 1-800-222-1222.
Directions
- shake well immediately before each use
- adults and children 12 years of age and older: 30 ml or 2 tablespoonful
- for accurate dosing, use convenient pre-measured dose cup
- repeat dose every 1/2 hour to 1 hour as needed
- do not exceed 8 doses 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
Other Information
- each 15mL tablespoon contains: sodium 10 mg
- each 15mL tablespoon contains: salicylate 130 mg
- do not use if printed inner seal is broken or missing
- store at room temperature
Inactive Ingredients
caramel, carboxymethylcellulose sodium, microcrystalline cellulose, natural and artificial flavor, potassium sorbate, salicylic acid , simethicone emulsion, sucralose, sucrose, water, xanthan gum
Questions Or Comments?
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Premier Value®
NDC 68016-317-12
COMPARE TO THE ACTIVE INGREDIENT IN KAOPECTATE®
Diarrhea Relief
VANILLA
Regular flavor
Bismuth Subsalicylate, 262 mg
- Anti-Diarrheal
- Upset Stomach Reliever
Effective Diarrhea Relief
Restores Natural Balance
Contains Salicylates
12 FL OZ (355 mL)
Distributed by:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087
*This product is not manufactured or distributed by Chattem Inc., the distributor of Kaopectate®.
Premier Value Diarrhea Relief Vanilla Flavor (Pb Original 01)
* Please review the disclaimer below.
