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| Product NDC Code | 37808-706 | ||||
|---|---|---|---|---|---|
| Drug Name | Gas relief infants |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | EMULSION | ||||
| RxCUI drug identifier | 198857 | ||||
| Application Number | part332 | ||||
| Labeler Name | H E B | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 0.3 mL) Simethicone 20 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 dose; otherwise, use age. • only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child. • remove cap and insert syringe into the bottle • pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (towards inner cheek). • 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 • dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids • replace cap tightly to maintain child resistance • mL = milliliter Age (yr) Weight (lb) Dose (mL) infants under 2 under 24 0.3 children over 2 over 24 0.6
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, flavor, hypromellose, maltitol solution, purified water, simethicone emulsion, sodium benzoate, sodium citrate, 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.Gas Relief Infants Simethicone DIMETHICONE DIMETHICONE SILICON DIOXIDE ANHYDROUS CITRIC ACID HYPROMELLOSES WATER SODIUM BENZOATE SODIUM CITRATE XANTHAN GUM white to off white, opaque
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 Compare to Infants’ Mylicon ® Drops Non-Staining active ingredient Infants’ Gas Relief Simethicone 20 mg Anti-Gas Pediatrician recommended #1 Active Ingredient Dye Free Drops Non-Staining No Alcohol Safe enough to use at every feeding** **use as directed 1 FL OZ (30 mL) infants gas relief image
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 (1-800-222-1222).
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? 1-800-719-9260
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 do not exceed 12 doses per day
Storage and handling
Information about safe storage and handling of the drug product.Other information • do not use if printed bottle wrap is broken or missing • store at 20-25°C (68-77°F) • do not freeze
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 When using this product do not exceed 12 doses per day Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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