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| Product NDC Code | 0536-1303 | ||||
|---|---|---|---|---|---|
| Drug Name | Infants |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SUSPENSION/ DROPS | ||||
| Application Number | M002 | ||||
| Labeler Name | RUGBY LABORATORIES | ||||
| 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, simply push syringe back until you have reached the described 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
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 Questions or comments? 1-800-645-2158
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.Infants Simethicone DIMETHICONE, UNSPECIFIED DIMETHICONE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS CITRIC ACID MICROCRYSTALLINE CELLULOSE POLYSORBATE 60 POTASSIUM SORBATE WATER SODIUM BENZOATE SORBITAN MONOSTEARATE SORBITOL 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 Rugby ® Compare to the active ingredient in Infants’ Mylicon ® Drops* NDC 0536-1303-75 Infants’ Simethicone Drops Antigas • Dye-free • Non-staining formula • No Saccharin • No Artificial Color • No Artificial Flavor 1 FL OZ (30 mL) 100 DOSES Distributed by: RUGBY LABORATORIES 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 www.rugbylaboratories.com Syringe Enclosed. This bottle contains 100 doses (0.3 mL/dose) *This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ MYLICON ® Drops. Rugbt Infants Simethicone Drops
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? 1-800-645-2158
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 at room temperature ▪ 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