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| Product NDC Code | 30142-171 | ||||
|---|---|---|---|---|---|
| Drug Name | Infants gas relief dye free |
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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 | THE KROGER CO. | ||||
| 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. • 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 or syringe to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child. • dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids • clean dropper well after each use-recap bottle with original cap • 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, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum Comments or Questions? 855-200-BABY www.ComfortsFor Baby.com
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 Gas Relief Dye Free Simethicone Antigas DIMETHICONE 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 NDC# 30142-171-01 Dye Free Drops INFANTS’ GAS RELIEF *compare to the active ingredient of INFANTS’ MYLICON ® DROPS *see the side panel Dye Free Drops INFANTS’ GAS RELIEF SIMETHICONE-ANTIGAS • Non-Staining formula • Gently Breaks Down Baby’s Gas Bubbles • No alcohol • No Artificial Colors or Flavor 1 Fl. OZ (30ml) 100 DOSES IMPORTANT: Keep this carton for future reference on full labeling DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 *THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY INFIRST HEALTHCARE INC., THE DISTRIBUTOR OF INFANTS’ MYLICON ® DROPS. INFIRST HEALTHCARE INC. IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT. Kroger Infants Gas Relief 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.Comments or Questions? 855-200-BABY www.ComfortsFor Baby.com
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