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| Product NDC Code | 55505-225 | ||||
|---|---|---|---|---|---|
| Drug Name | Extra strength gas relief |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 2262288 | ||||
| Application Number | M002 | ||||
| Labeler Name | KRAMER LABORATORIES | ||||
| 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 5 mL) Simethicone 125 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 using ▪ do not take more than 20 mL in any 24-hour period except under the advice and supervision of a physician ▪ measure only with dosing cup provided ▪ do not use dosing cup with other products ▪ mL = milliliter ▪ adults : 5 mL or 10 mL in dosing cup provided as needed after meals and at bedtime.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carboxymethylcellulose sodium, citric acid anhydrous, flavor, glycerin, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, sucralose, xanthan 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 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.EXTRA STRENGTH gas relief SIMETHICONE DIMETHICONE DIMETHICONE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS CITRIC ACID GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 60 POTASSIUM SORBATE WATER SODIUM BENZOATE SORBITAN MONOSTEARATE SORBITOL SUCRALOSE XANTHAN GUM
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 SAFE AND EFFECTIVE RELIEF RELIEVES GAS FAST NDC# 55505-225-36 Kaopectate® Simethicone 125mg Anti-gas Extra Strength Gas Relief Liquid ✓ Pressure ✓ Bloating ✓ Discomfort Starts to work in minutes • Dye-free • Sugar-free Berry Flavor 48 DOSES Dosage cup inside 8 FL OZ (237 mL) IMPORTANT: Keep this carton for future reference on full labeling. Distributed by Kramer Laboratories, Inc., Bridgewater, NJ, 08807 1-800-824-4894 TAMPER EVIDENT: Do not use if foil seal under cap, printed with “SEALED FOR YOUR PROTECTION” is missing, open or broken. Kaopectate Extra Strength Gas Relief Liquid Berry Flavor
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 at 1-800-222-1222. Quick medical attention is critical even if you do not notice any sign or symptoms.
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 1-800-824-4894
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information ▪ Each 5 mL contains: sodium 2 mg ▪ store at 20° – 25°C (68° – 77°F ) ▪ do not refrigerate ▪ protect from light, heat, and moisture
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 If pregnant or breast-feeding, ask a health professional before use. 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. Quick medical attention is critical even if you do not notice any sign or symptoms.
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