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| Product NDC Code | 59556-853 | ||||
|---|---|---|---|---|---|
| Drug Name | Pediacare simethicone antigas |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | EMULSION | ||||
| Application Number | part332 | ||||
| Labeler Name | Strides Pharma 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 ingredient (in each 0.3 mL) Simethicone 20 mg (provided as simethicone emulsion 66.7 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 find right dose on chart below. If possible, use weight to determine dose; otherwise, use age. measure only with the enclosed syringe remove cap and insert syringe into the bottle. Fill syringe to recommended dosage level. dispense liquid slowly into child's mouth, toward inner cheek may be mixed with 1 oz. of cool water, infant formula or other suitable liquids all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician do not exceed 12 doses per day clean syringe and replace cap tightly on bottle mL = millilitre Age(yrs) weight(lbs) dose infants under 2 under 24 0.3mL children 2 and over 24 and over 0.6mL
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| infants under 2 | under 24 | 0.3mL |
| children 2 and over | 24 and over | 0.6mL |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carboxymethylcellulose sodium, citric acid, flavor, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate , 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 relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods
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.Pediacare SIMETHICONE ANTIGAS simethicone SILICON DIOXIDE SILICON DIOXIDE DIMETHICONE DIMETHICONE CARBOXYMETHYLCELLULOSE SODIUM CITRIC ACID MONOHYDRATE MICROCRYSTALLINE CELLULOSE PROPYLENE GLYCOL SODIUM BENZOATE SUCRALOSE WATER 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 INFANTS 0-36 months PediaCare ® Gas Relief DROPS SIMETHICONE-ANTIGAS DYE-FREE Berry Flavor 1 FL OZ (30 mL) Carton Label Carton 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.Drug Facts
Pediacare SIMETHICONE ANTIGAS: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Other information do not freeze store at 20°-25°C (68°-77°F)
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 (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions 1-888-474-3099 Monday – Friday 8 am to 5 pm Eastern standard time. PediaCare.com
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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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