Aspire Daytime Mucus and Sinus Softgel

Manufacturer
Aspire Pharmaceuticals Inc. | Dr Madhav Pai
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:41:09

Label at a glance#

ProductAspire Day Congestion and Headache Softgel
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN
Label structure45 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

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.

WARNINGS SECTION

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.
  • 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 have

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • 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

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, 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.

INDICATIONS & USAGE SECTION

USES

  • Temporarily relieves these common cold and flu symptoms:

Nasal congestion

Headache

Cough

Minor aches and pains

Sore throat

  • Temporarily reduces fever
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

Polyethylene Glycol, Unspecified

Propylene Glycol

Povidone, Unspecified

Gelatin, Unspecified

Glycerin

Sorbitol

Purified Water

Lecithin, Sunflower

Light Mineral oil

FD&C Colors

OTC - ASK DOCTOR SECTION

​ Ask a doctor before use if you have

  • Liver disease
  • Heart disease
  • Diabetes
  • High blood pressure
  • Thyroid disease
  • Trouble urinating due to an enlarged prostate gland
  • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Cough that occurs with too much phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - DO NOT USE SECTION

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.
  • 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 SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - PURPOSE SECTION

Active Ingredient Purpose

Acetaminophen 325 mg -Pain reliever/fever reducer
Dextromethorphan HBr 10 mg -Cough suppressant
Guaifenesin 200 mg -Expectorant
Phenylephrine HCl 5 mg -Nasal Decongestant

OTC - QUESTIONS SECTION

1-732-447-1444

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Nervousness, dizziness, or sleeplessness occur
  • Pain, nasal congestion, 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.

OTC - WHEN USING SECTION

When using this product do not use more than directed

OTC - ACTIVE INGREDIENT SECTION

Active ingredients in each liquid gel -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 Decongestant

DOSAGE & ADMINISTRATION SECTION

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

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.

WARNINGS SECTION

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.
  • 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 have

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • breathing problems such as emphysema or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, 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.

INDICATIONS & USAGE SECTION

USES

  • temporarily relieves these common cold and flu symptoms:
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
  • temporarily reduces fever
  • controls cough to help you get to sleep

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

Polyethylene Glycol, Unspecified

Propylene Glycol

Povidone, Unspecified

Gelatin, Unspecified

Glycerin

Sorbitol

Purified Water

Lecithin, Sunflower

Light Mineral oil

FD&C Colors

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • Liver disease
  • Heart disease
  • Diabetes
  • High blood pressure
  • Thyroid disease
  • Glaucoma
  • Trouble urinating due to an enlarged prostate gland
  • Breathing problems such as emphysema or chronic bronchitis
  • Cough that occurs with too much phlegm (mucus)
  • Persistent or chronic cough such as occurs with smoking, asthma, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • Taking the blood thinning drug warfarin
  • Taking sedatives or tranquilizers

OTC - DO NOT USE SECTION

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.
  • 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 SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - PURPOSE SECTION

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

OTC - QUESTIONS SECTION

1-732-447-1444

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Nervousness, dizziness, or sleeplessness occur
  • Pain, nasal congestion, 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.

OTC - WHEN USING SECTION

When using this product

  • Do not use more than directed
  • Excitability may occur, especially in children
  • Marked drowsiness may occur
  • Alcohol, sedatives, and tranquilizers may increase drowsiness
  • Avoid alcoholic drinks
  • Be careful when driving a motor vehicle or operating machinery

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each liquid gel) Purposes

Acetaminophen 325 mg -Pain reliever/fever reducer

Dextromethorphan HBr 10 mg -Cough suppressant

Phenylephrine HCl 5 mg -Nasal decongestant

DOSAGE & ADMINISTRATION SECTION

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

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.

WARNINGS SECTION

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.

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.
  • 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 have

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, 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

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, 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.

INDICATIONS & USAGE SECTION

USES

  • temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • cough
  • headache
  • minor aches and pains
  • sinus congestion and pressure
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

Polyethylene Glycol, Unspecified

Propylene Glycol

Povidone, Unspecified

Gelatin, Unspecified

Glycerin

Sorbitol

Purified Water

Lecithin, Sunflower

Light Mineral oil

FD&C Colors

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • Liver disease
  • Heart disease
  • Diabetes
  • High blood pressure
  • Thyroid disease
  • Trouble urinating due to an enlarged prostate gland
  • Persistent or chronic cough such as occurs with smoking, asthma, 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

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, 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.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - DO NOT USE SECTION

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.
  • 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 SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - PURPOSE SECTION

Active ingredients (in each liquid gel) Purposes

Acetaminophen 325 mg -Pain reliever/fever reducer

Dextromethorphan HBr 10 mg -Cough suppressant

Phenylephrine HCl 5 mg -Nasal decongestant

OTC - QUESTIONS SECTION

1-732-447-1444

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Nervousness, dizziness, or sleeplessness occur
  • Pain, nasal congestion, 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.

OTC - WHEN USING SECTION

When using this product do not use more than directed

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspire Daytime Mucus and Sinus SoftgelAspire Daytime Mucus and Sinus Softgel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspire Night Cold and Flu SoftgelsAspire Night Cold and Flu Softgels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspire Day Congestion and Headache SoftgelsAspire Day Congestion and Headache Softgels

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81013-10181013-101-01
81013-10281013-102-01
81013-10381013-103-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f1f406b0-c983-63ab-e053-2a95a90ad8c3b3397e24-4cda-ac0a-e053-2a95a90afae22023-01-10WarningsExact identifier
spl id: f1f406b0-c983-63ab-e053-2a95a90ad8c3
spl set id: b3397e24-4cda-ac0a-e053-2a95a90afae2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.