Cvs Health Anti Gas
Simethicone
Cvs Pharmacy
Human Otc Drug
NDC 69842-977Cvs Health Anti Gas also known as Simethicone is a human otc drug labeled by 'Cvs Pharmacy'. National Drug Code (NDC) number for Cvs Health Anti Gas is 69842-977. This drug is available in dosage form of Suspension/ Drops. The names of the active, medicinal ingredients in Cvs Health Anti Gas drug includes Dimethicone - 20 mg/.3mL . The currest status of Cvs Health Anti Gas drug is Active.
Drug Information:
| Drug NDC: | 69842-977 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Cvs Health Anti Gas |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Simethicone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cvs Pharmacy |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suspension/ Drops |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DIMETHICONE - 20 mg/.3mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 10 Apr, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part332 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | CVS PHARMACY
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198857
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0050428421673
|
| UPC stands for Universal Product Code. |
| NUI: | N0000010282
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 92RU3N3Y1O
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class PE: | Skin Barrier Activity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Skin Barrier Activity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69842-977-01 | 1 BOTTLE, DROPPER in 1 CARTON (69842-977-01) / 30 mL in 1 BOTTLE, DROPPER | 10 Apr, 2019 | N/A | No |
| 69842-977-15 | 1 BOTTLE, DROPPER in 1 CARTON (69842-977-15) / 15 mL in 1 BOTTLE, DROPPER | 10 Apr, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antigas
Product Elements:
Cvs health anti gas simethicone dimethicone dimethicone carboxymethylcellulose sodium, unspecified anhydrous citric acid microcrystalline cellulose polysorbate 60 potassium sorbate water sodium benzoate sorbitan monostearate sorbitol xanthan gum
Indications and Usage:
Uses relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods
Warnings:
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.
Dosage and Administration:
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 childs 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
Package Label Principal Display Panel:
Principal display panel cvs health® compare to the active ingredient in infants mylicon ® drops * ndc 69842-977-01 infants gas relief simethicone /anti-gas supports babys body in relieving gas anti-gas safe enough to use at every feeding non-staining dye free actual product size on side panel 1 fl oz (30ml) *this product is not manufactured or distributed by infirst healthcare inc., the distributor of infants mylicon ® drops.. this medicine in cvs health® gas relief drops breaks down gas bubbles, helping a babys natural process of expelling gas. distributed by: cvs pharmacy, inc. one cvs drive, woonsocket, ri 02895 @ 2020 cvs/pharmacy cvs.com ® 1-800-shop cvs v-12431 cvs quality money back guarantee important: keep this carton for future reference on full labeling package label infants gas relief dye-free formula 100 doses package label for infants gas relief 50 doses package label for infants gas relief dye free formula 50 doses package label for infants gas relief dye free formula 100 doses
Further Questions:
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