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| Product NDC Code | 0132-0507 | ||||
|---|---|---|---|---|---|
| Drug Name | Phazyme |
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| Type | Brand | ||||
| Pharm Class | Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Skin Barrier Activity [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 1741562, 1741569 |
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| Application Number | part332 | ||||
| Labeler Name | C.B. Fleet Company, 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 Ingredients (in each chew) Calcium carbonate 750mg............... Antacid Simethicone 250mg.................. Anti-gas
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 Adults and children 12 years and older: Chew and swallow 1 to 2 chews as symptoms occur or as directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Acacia, beeswax, carnuba wax, citric acid, cornstarch, corn syrup, FD&C red #40 aluminum lake, flavor, modified starch, phosphoric acid, polyvinylpyrolidone, pregelatinized modified corn starch, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, vegetable oil, water
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 for the relief of: pressure and bloating commonly referred to as gas acid indigestion heartburn sour stomach upset stomach associated with these symptoms
Purpose
Information about the drug product’s indications for use.Other Information Each chew contains: calcium 300mg Store between 59-77F. Don't use if allergic to this product or its ingredients.
Spl product data elements
Usually a list of ingredients in a drug product.PHAZYME Simethicone and Calcium Carbonate CALCIUM CARBONATE CALCIUM CATION DIMETHICONE DIMETHICONE ACACIA YELLOW WAX CARNAUBA WAX CITRIC ACID ACETATE STARCH, CORN CORN SYRUP FD&C RED NO. 40 MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) PHOSPHORIC ACID PROPYLENE GLYCOL SHELLAC SODIUM BENZOATE SORBIC ACID SORBITOL LECITHIN, SOYBEAN SUCROSE TITANIUM DIOXIDE WATER PA
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.Principle Display Panel Phazyme Gas & Acid Chews Bottle
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 or pharmacist before use if you are Now taking a prescription drug. Antacids may interact with certain prescription drugs.
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 Keep out of reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-855-727-4277 or www.phazyme.com
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.If pregnant or breast-feeding Ask a doctor 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.When using this product do not take more than 2 chews in a 24-hour period do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a doctor
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