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| Product NDC Code | 62372-630 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Mylicon infants gas relief original |
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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, 809376 |
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| Application Number | M002 | ||||||
| Labeler Name | Infirst Healthcare | ||||||
| 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
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 (toward 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carboxymethylcellulose sodium, citric acid, D&C Red 22, D&C Red 28, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, 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 discomfort of infant 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.Mylicon Infants Gas Relief Original Simethicone CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM ANHYDROUS CITRIC ACID D&C RED NO. 22 D&C RED NO. 28 MICROCRYSTALLINE CELLULOSE POLYSORBATE 60 POTASSIUM SORBATE WATER SODIUM BENZOATE SORBITAN MONOSTEARATE SORBITOL XANTHAN GUM DIMETHICONE DIMETHICONE pink
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' Mylicon® Simethicone-Antigas Gas Relief Gently breaks down baby’s gas bubbles Original Drops Non-staining Safe enough to use at every feeding and up to 12 times per day* #1 Brand Recommended by Pediatricians 1 Fl. OZ (30ml) 100 Doses Visit us at mylicon.com No Alcohol No Artificial Flavors No Saccharin Gluten Free Safe enough to use at every feeding and up to 12 times per day* Safe enough for even the newest of newborns* *use as directed Mylicon is a registered trademark of McNeil Consumer Pharmaceuticals Co. Important: Keep this carton for future reference on full labeling Manufactured for infirst Healthcare Inc. Westport, CT 06880 ©2015 infirst Healthcare Inc. Package Label for 30 mL Package Label for 15 mL Infants Mylicon Gas relief Original Infants Gas Relief Original Drops 15 mL
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
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. Overdose warning: 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 signs 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 1-855-848-3284 toll free (English and Spanish)
Storage and handling
Information about safe storage and handling of the drug product.Other information tamper evident: do not use if printed seal under cap is broken or missing store between 20-25°C (68-77°F) do not freeze see bottom panel for lot number and expiration date
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. Overdose warning: 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 signs 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