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#
Contacts and useful links#
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 81013-104-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-af04-d83d-e063-dadaa90ab31f | dbc517f5-ac4e-6ad3-e053-2a95a90a5aee |
Products#
Every source-derived product name is available through these pages.
- Aspire Congestion and Cough Relief DM Softgels
- POLYETHYLENE GLYCOL 400
- GLYCERIN
- FD&C BLUE NO. 1
- PROPYLENE GLYCOL
- POVIDONE K12
- WATER
- GUAIFENESIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- TITANIUM DIOXIDE
- D&C YELLOW NO. 10
- LIGHT MINERAL OIL
- LECITHIN, SUNFLOWER
- GELATIN, UNSPECIFIED
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81013-104 | 81013-104-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POVIDONE K12 | 333AG72FWJ | IACT |
| WATER | 059QF0KO0R | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| LECITHIN, SUNFLOWER | 834K0WOS5G | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| SORBITOL | 506T60A25R | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f43a9389-c644-ce49-e053-2a95a90a537f | dbc517f5-ac4e-6ad3-e053-2a95a90a5aee | 2023-02-08 | Warnings | f43a9389-c644-ce49-e053-2a95a90a537f dbc517f5-ac4e-6ad3-e053-2a95a90a5aee |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
