NDC 81013-101 Aspire Daytime Mucus And Sinus Softgel

Aspire Daytime Mucus And Sinus Softgel

NDC Product Code 81013-101

NDC CODE: 81013-101

Proprietary Name: Aspire Daytime Mucus And Sinus Softgel What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Aspire Daytime Mucus And Sinus Softgel What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
RED (C48326)
GREEN (C48329)
ORANGE (C48331)
Shape: OVAL (C48345)
Size(s):
17 MM
22 MM
Imprint(s):
AR04
AR03
AR01
Score: 1

NDC Code Structure

  • 81013 - Aspire Pharmaceuticals Inc.
    • 81013-101 - Aspire Daytime Mucus And Sinus Softgel

NDC 81013-101-01

Package Description: 4000 CAPSULE, LIQUID FILLED in 1 BAG

NDC Product Information

Aspire Daytime Mucus And Sinus Softgel with NDC 81013-101 is a a human over the counter drug product labeled by Aspire Pharmaceuticals Inc.. The generic name of Aspire Daytime Mucus And Sinus Softgel is aspire daytime mucus and sinus softgel. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Aspire Pharmaceuticals Inc.

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Aspire Daytime Mucus And Sinus Softgel Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Aspire Pharmaceuticals Inc.
Labeler Code: 81013
FDA Application Number: part341 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 03-17-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Aspire Daytime Mucus And Sinus Softgel Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active ingredients (in each liquid gel) Purposes
Acetaminophen 325 mg - Pain reliever/fever reducer

Dextromethorphan HBr 10 mg - Cough suppressant

Guaifenesin 200 mg - Expectorant

Phenylephrine HCl 5 mg - Nasal decongestant

Active ingredients in each liquid gel -Purposes Acetaminophen 325 mg-Pain reliever/fever reducerDextromethorphan HBr 10 mg -Cough suppressantGuaifenesin 200 mg - ExpectorantPhenylephrine HCl 5 mg-Nasal decongestant

Active ingredients (in each liquid gel) PurposesAcetaminophen 325 mg -Pain reliever/fever reducerDextromethorphan HBr 10 mg -Cough suppressantPhenylephrine HCl 5 mg -Nasal decongestant

Dosage & Administration

  • DIRECTIONSDo not take more than directed (see OVERDOSE WARNING)Do not take more than 12 liquid gels in any 24-hour periodAdults and children 12 years of age and older: take 2 liquid gels every 4 hoursChildren under 12 years of age: do not useOverdose warningTaking 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.

Warnings

  • WARNINGSLiver warningThis product contains acetaminophen. Severe liver damage may occur if you take:more than 12 liquid gels in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 or more alcoholic drinks daily while using this productAllergy alertAcetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.Sore throat warningIf 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 usewith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.Ask a doctor before use if you haveliver diseaseheart diseasediabeteshigh blood pressurethyroid diseasetrouble urinating due to an enlarged prostate glandpersistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysemacough 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 directedStop use and ask a doctor ifnervousness, dizziness, or sleeplessness occurpain, nasal congestion, or cough gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough 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 warningTaking 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.

Indications & Usage

  • USESTemporarily relieves these common cold and flu symptoms: Nasal congestion Headache Cough Minor aches and pains Sore throatTemporarily reduces feverHelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Inactive Ingredient

INACTIVE INGREDIENTSPolyethylene Glycol Propylene GlycolPovidoneGelatinGlycerin Sorbitol Sorbitan SolutionPurified WaterFD&C ColorsPurified Water

Otc - Ask Doctor

  • Ask a doctor before use if you haveLiver diseaseHeart diseaseDiabetesHigh blood pressureThyroid diseaseTrouble urinating due to an enlarged prostate glandPersistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysemaCough that occurs with too much phlegm (mucus)

  • Ask a doctor before use if you haveLiver diseaseHeart diseaseDiabetesHigh blood pressureThyroid diseaseGlaucomaTrouble urinating due to an enlarged prostate glandBreathing problems such as emphysema or chronic bronchitisCough that occurs with too much phlegm (mucus)Persistent or chronic cough such as occurs with smoking, asthma, or emphysema

  • Ask a doctor before use if you haveLiver diseaseHeart diseaseDiabetesHigh blood pressureThyroid diseaseTrouble urinating due to an enlarged prostate glandPersistent or chronic cough such as occurs with smoking, asthma, or emphysemaCough that occurs with too much phlegm (mucus)

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

  • Ask a doctor or pharmacist before use if you areTaking the blood thinning drug warfarinTaking sedatives or tranquilizers

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Otc - Do Not Use

  • Do not useWith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • Do not useWith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • Do not useWith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Keep out of reach of children.

Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

Otc - Purpose

Active Ingredient PurposeAcetaminophen 325 mg -Pain reliever/fever reducer

Dextromethorphan HBr 10 mg -Cough suppressant

Guaifenesin 200 mg -Expectorant

Phenylephrine HCl 5 mg -Nasal decongestant

Active ingredients Purposes
Acetaminophen 325 mg -Pain reliever/fever reducer

Dextromethorphan HBr 10 mg -Cough suppressant

Doxylamine succinate 6.25 mg -Antihistamine

Phenylephrine HCl 5 mg -Nasal decongestan

Active ingredients (in each liquid gel) PurposesAcetaminophen 325 mg -Pain reliever/fever reducerDextromethorphan HBr 10 mg -Cough suppressantPhenylephrine HCl 5 mg -Nasal decongestant

Otc - Questions

1-732-447-1444

1-732-447-1444

1-732-447-1444

Otc - Stop Use

  • Stop use and ask a doctor ifNervousness, dizziness, or sleeplessness occurPain, nasal congestion, or cough gets worse or lasts more than 7 daysFever gets worse or lasts more than 3 daysRedness or swelling is presentNew symptoms occurCough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

  • Stop use and ask a doctor ifNervousness, dizziness, or sleeplessness occurPain, nasal congestion, or cough gets worse or lasts more than 7 daysFever gets worse or lasts more than 3 daysRedness or swelling is presentNew symptoms occurCough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

  • Stop use and ask a doctor ifNervousness, dizziness, or sleeplessness occurPain, nasal congestion, or cough gets worse or lasts more than 7 daysFever gets worse or lasts more than 3 daysRedness or swelling is presentNew symptoms occurCough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

Otc - When Using

When using this product do not use more than directed


When using this product do not use more than directed

* Please review the disclaimer below.