Aspire Mucus And Pain Relief Softgels

Aspire Pharmaceuticals Inc.
Human Otc Drug
NDC 81013-105

Aspire Mucus And Pain Relief Softgels is a human otc drug labeled by 'Aspire Pharmaceuticals Inc.'. National Drug Code (NDC) number for Aspire Mucus And Pain Relief Softgels is 81013-105. This drug is available in dosage form of Capsule, Liquid Filled. The names of the active, medicinal ingredients in Aspire Mucus And Pain Relief Softgels drug includes Acetaminophen - 325 mg/1 Guaifenesin - 200 mg/1 . The currest status of Aspire Mucus And Pain Relief Softgels drug is Active.

Drug Information:

Drug NDC:	81013-105
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:	Aspire Mucus And Pain Relief Softgels
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:	Aspire Mucus And Pain Relief Softgels
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Aspire Pharmaceuticals Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Capsule, Liquid Filled
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:	ACETAMINOPHEN - 325 mg/1 GUAIFENESIN - 200 mg/1
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:	14 Apr, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	23 Jun, 2026
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:	part341
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, 2024
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:	Aspire Pharmaceuticals Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	707195
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.
NUI:	N0000193956 N0000008867 N0000009560
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	362O9ITL9D 495W7451VQ
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 EPC:	Expectorant [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Decreased Respiratory Secretion Viscosity [PE] Increased Respiratory Secretions [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:	Decreased Respiratory Secretion Viscosity [PE] Expectorant [EPC] Increased Respiratory Secretions [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
81013-105-01	6000 CAPSULE, LIQUID FILLED in 1 BAG (81013-105-01)	14 Apr, 2022	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.

Other medicines with the same generic name

Aspire Mucus And Pain Relief Softgels

Capsule, Liquid Filled
Aspire Pharmaceuticals Inc.
NDC: 81013-105

Purpose:

Active ingredient purpose acetaminophen 325 mg - pain reliever/fever reduce guaifenesin 200 mg -expectorant

Product Elements:

Aspire mucus and pain relief softgels aspire mucus and pain relief softgels propylene glycol povidone k30 gelatin, unspecified water fd&c blue no. 1 titanium dioxide light mineral oil sorbitol polyethylene glycol 400 glycerin acetaminophen acetaminophen guaifenesin guaifenesin lecithin, sunflower ar09 oblong shape opaque navy blue

Indications and Usage:

Uses temporarily relieves these common cold and flu symptoms: headache minor aches and pains sore throat helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily reduces fever

Warnings:

(mucus) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin when using this product do not use more than directed stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do Not Use:

Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take: more than 12 liquid gels in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product allergy alert acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away. sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if you have liver disease persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin when using this product do not use more than directed stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

When Using:

When using this product do not use more than directed

Dosage and Administration:

Directions do not take more than directed (see overdose warning) do not take more than 12 liquid gels in any 24-hour period adults and children 12 years of age and older: take 2 liquid gels every 4 hours children under 12 years of age: do not use

Stop Use:

Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition.

Package Label Principal Display Panel:

Aspire mucus and pain relief softgels rev-01

Further Questions:

1-732-447-1444

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.