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| Product NDC Code | 76281-537 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Stomach relief - regular strength |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 308762 | ||||||
| Application Number | M008 | ||||||
| Labeler Name | AptaPharma Inc. | ||||||
| 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 cup or 2 tablespoons) 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 ■ use dose cup or tablespoon (TBSP) ■ adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour as needed ■ do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours ■ use until diarrhea stops but not more than 2 days ■ children under 12 years: ask adoctor ■ 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, purified water, saccharin sodium, salicylic acid, sodium salicylate, xantham 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 of food and drink including: ■ heart burn ■ indigestion ■ nausea ■ gas ■ belching
Purpose
Information about the drug product’s indications for use.Purposes Bismuth subsalicylate .............. Upset stomach reliever and antidiarrheal
Spl product data elements
Usually a list of ingredients in a drug product.Stomach Relief - Regular Strength BISMUTH SUBSALICYLATE BISMUTH SUBSALICYLATE SALICYLIC ACID BENZOIC ACID D&C RED NO. 22 D&C RED NO. 28 WATER SACCHARIN SODIUM SALICYLIC ACID SODIUM SALICYLATE XANTHAN GUM color suspension
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 AP SAFE NDC 76281-537-28 *COMPARE TO the active ingredient in PEPTO-BISMOL™ Stomach Relief Bismuth Subsalicylate Antidiarrheal / Upset Stomach Reliever Regular Strength 5 Symptom Relief of: ● Nausea ● Heartburn ●Indigestion ● Upset stomach ● Diarrhea 12 FL OZ (354 mL) TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken *This product is not manufactured or distributed by Procter & Gamble, Inc., the distributor of Pepto-Bismol ™ . Made in USA AP-LR-11 REV01 Manufactured by: AptaPharma Inc., 1533 Union Ave. Pennsauken, NJ 08110 3 76281 53728 4 12 OZ 6 OZ Stomach Relief - Regular Strength by AptaPharma Inc. res Stomache Relief Reg 12 OZ 537-25 6OZ
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
Allergy alert: Contains salicylate. Do not take if you are ■ allergic to salicylates (including aspirin) ■ taking other salicylate products
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 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 of 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 ■ black or bloody 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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ each 30 mL dose cup contains: sodium 13 mg, salicylate 256 mg ■ protect from freezing ■ avoid excessive heat (over 104ºF or 40ºC) ■ Low sodium
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-877-798-5944
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.Slop use and ask a doctor if ■ diarrhea lasts more than 2 days ■ symptoms get worse or last more than 2 days ■ ringing in the ears or loss of hearing occurs
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 health professional before use.
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.
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