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| Product NDC Code | 68016-670 | ||||
|---|---|---|---|---|---|
| Drug Name | Premier value infants gas relief |
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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 | M002 | ||||
| Labeler Name | Chain Drug Consortium | ||||
| 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 ▪ 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. ▪ fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek ▪ dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids ▪ clean dropper after each use - replace bottle with original cap age (yr) weight (lb) dose infants under 2 under 24 0.3 mL children over 2 over 24 0.6 mL
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carboxymethylcellulose sodium, citric acid, flavors, microcrystalline cellulose, 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.premier value infants gas relief Simethicone DIMETHICONE DIMETHICONE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS CITRIC ACID MICROCRYSTALLINE CELLULOSE POLYSORBATE 60 POTASSIUM SORBATE WATER SODIUM BENZOATE SORBITAN MONOSTEARATE SORBITOL 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 ACTIVE INGREDIENT IN INFANTS' MYLICON® DROPS* Premier Value ® Infants' Gas Relief Non-Staining formula Simethicone 20 mg/Antigas • Dye Free • No Saccharin • No Artificial Colors • No Artificial flavors Syringe Enclosed. This Bottle contains 100 doses (0.3 mL/dose) 1 Fl. OZ (30ml) 100 Doses Distributed by Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 *This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon ® Drops. Premier Value Infants' Gas Relief Permier Value Infants' Gas Relief
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.
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 torn or missing ▪ store at room temperature ▪ do not freeze ▪ see bottom panel for lot 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. In case of overdose get medical help or contact a poison control center 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