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| Product NDC Code | 69618-059 | ||||
|---|---|---|---|---|---|
| Drug Name | Infants gas relief drops |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SUSPENSION/ DROPS | ||||
| RxCUI drug identifier | 198857 | ||||
| Application Number | M002 | ||||
| Labeler Name | RELIABLE 1 LABORATORIES | ||||
| 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 only use the enclosed dropper 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. of cool water, infant formula or other suitable liquids clean dropper well after each use and replace original cap on bottle Age (years) Weight (lbs) Dose infants (under 2) under 24 0.3 mL children (2 and over) 24 and over 0.6 mL
| infants (under 2) | under 24 | 0.3 mL |
| children (2 and over) | 24 and over | 0.6 mL |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, 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.Use relieves the symptoms referred to as gas
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 DROPS Simethicone CARBOXYMETHYLCELLULOSE SODIUM ANHYDROUS CITRIC ACID MALTITOL CELLULOSE, MICROCRYSTALLINE WATER SODIUM BENZOATE SODIUM CITRATE XANTHAN GUM DIMETHICONE DIMETHICONE off-white
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.package Label 1
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.
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 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday
Storage and handling
Information about safe storage and handling of the drug product.Other information TAMPER-EVIDENT: Do not use if foil seal under the 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. 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