Aspire Congestion and Cough Relief DM 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 Congestion and Cough Relief DM Softgels
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each liquid gel) Purposes

Dextromethorphan HBr 10 mg – Cough Suppressant

Guaifenesin 200 mg - Expectorant

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

  • Do not take more than 12 liquid gels in any 24-hour period
  • Adults and children 12 years of age and over: take 2 liquid gels every 4 hours
  • Children under 12 years of age: do not use

INDICATIONS & USAGE SECTION

USES

  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Temporarily relieves:
  • Cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • The intensity of coughing
  • The impulse to cough to help you get to sleep

WARNINGS AND PRECAUTIONS SECTION

Do not use

  • If you are now taking a prescription monamine 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 and MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Cough that occurs with too much phlegm (mucus)

When using this product do not use more than directed

Stop use and ask a doctor if

  • Cough lasts more than 7 days, comes back, or occurs with fever, 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.

INACTIVE INGREDIENT SECTION

D&C yellow no. 10, FD&C blue no. 1, Gelatin, Glycerin, 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

  • 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 your prescription drug contains and MAOI

OTC - DO NOT USE SECTION

Do not use

  • If you are now taking a prescription monamine 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 and 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

Guaifenesin 200 mg -Expectorant

Dextromethorphan HBr 10 mg -Cough suppressant

OTC - QUESTIONS SECTION

1-732-447-1444

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Cough lasts more than 7 days, comes back, or occurs with fever, 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

WARNINGS SECTION

Do not use

  • If you are now taking a prescription monamine 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 and MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

When using this product do not use more than directed

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspire Congestion and Cough Relief DM Softgels -Rev-01Aspire Congestion and Cough Relief DM Softgels -Rev-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81013-104-012025-01-30C16284748780-12cef2736-af04-d83d-e063-dadaa90ab31fdbc517f5-ac4e-6ad3-e053-2a95a90a5aee

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81013-10481013-104-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
f43a9389-c644-ce49-e053-2a95a90a537fdbc517f5-ac4e-6ad3-e053-2a95a90a5aee2023-02-08WarningsExact identifier
spl id: f43a9389-c644-ce49-e053-2a95a90a537f
spl set id: dbc517f5-ac4e-6ad3-e053-2a95a90a5aee

Reported adverse events (FAERS/openFDA)#

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