Aspire Mucus and Pain Relief Softgels

Manufacturer
Aspire Pharmaceuticals Inc. | Dr Madhav Pai
Effective date
2023-02-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:37:10

Label at a glance#

ProductAspire Mucus and Pain Relief Softgels
Active ingredientACETAMINOPHEN, GUAIFENESIN
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each liquid gel) Purposes
Acetaminophen 325 mg - Pain reliever/fever reducer
Guaifenesin 200 mg - Expectorant

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

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.

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.

INDICATIONS & USAGE SECTION

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

INACTIVE INGREDIENT SECTION

FD&C blue no. 1, Gelatin, Glycerin, Hypromellose, Lecithin, Light mineral oil, Polyethylene glycol, Povidone, Propylene glycol, Purified water, Sorbitol sorbitan solution, Titanium dioxide

OTC - ASK DOCTOR SECTION

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)

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.

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 reduce

Guaifenesin 200 mg -Expectorant

OTC - QUESTIONS SECTION

1-732-447-1444

OTC - STOP USE SECTION

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.

OTC - WHEN USING SECTION

When using this product do not use more than directed

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspire Mucus and Pain Relief Softgels Rev-01Aspire Mucus and Pain Relief Softgels Rev-01

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128MMM YYYYAspire Mucus and Pain Relief Softgels Rev-01.jpg
Data codeCode 128OTCXXXXAspire Mucus and Pain Relief Softgels Rev-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81013-105-012025-01-30C16284748780-12cef2736-7426-d83d-e063-dadaa90ab31fdbc83501-9401-2a8d-e053-2a95a90a45c5

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81013-10581013-105-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
f43ab341-0829-b18c-e053-2995a90ac22bdbc83501-9401-2a8d-e053-2a95a90a45c52023-02-08WarningsExact identifier
spl id: f43ab341-0829-b18c-e053-2995a90ac22b
spl set id: dbc83501-9401-2a8d-e053-2a95a90a45c5

Reported adverse events (FAERS/openFDA)#

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