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| Product NDC Code | 71594-707 | ||||
|---|---|---|---|---|---|
| Drug Name | Firstcare maximum strength gas relief simethicone 250 mg anti-gas |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 2595235 | ||||
| Application Number | part332 | ||||
| Labeler Name | USpharma Ltd | ||||
| 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 chewable) Simethicone, 250 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 adults and children 12 years and older: take 1 or 2 chewables as needed after meals and at bedtime. do not exceed 2 chewables in 24 hours except under the advice and supervision of a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: carnauba wax, citric acid, croscarmellose sodium, crospovidone, FD&C red #40, flavors, glucose syrup, glycerin, gum arabic, maltitol solution,mannitol, powdered milk, propylene glycol, sorbitol, starch, sucralose, sucrose.
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, bloating, and fullness commonly referred to as gas
Purpose
Information about the drug product’s indications for use.Purpose Antigas
Spl product data elements
Usually a list of ingredients in a drug product.Firstcare Maximum Strength Gas Relief Simethicone 250 mg Anti-gas Simethicone CARNAUBA WAX ANHYDROUS CITRIC ACID CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C RED NO. 40 CORN SYRUP GLYCERIN ACACIA MALTITOL MANNITOL MILK PROTEIN CONCENTRATE PROPYLENE GLYCOL SORBITOL STARCH, CORN SUCRALOSE SUCROSE DIMETHICONE DIMETHICONE 7 MIXED BERRY
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-250 mg bottle label FIRSTCARE MADE IN USA NDC 71594-707-08 MAXIMUM STRENGTH GAS RELIEF SIMETHICONE 250 mg Anti-gas Fast Relief of: Bloating, Pressure, Gas discomfort Mixed Berry Flavor 20 SOFT CHEWABLES Principal display Panel-250 mg bottle label
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.Other information each chewable contains sodium 5 mg. very low sodium store at controlled room temperature 20-25°C (68-77°F). protect from light, heat and moisture. Child Resistant Container; do not use if printed seal under cap is broken or missing.
USpharma 13900 NW 57th Court, Miami Lakes, FL 33014 1-800-227-6151 www.uspharmaltd.com
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 accidental overdose, seek professional assistance or contact a poison control center immediately.
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? Call 1-800-227-6151
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.Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
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