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#
Contacts and useful links#
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
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | MMM YYYY | Aspire Mucus and Pain Relief Softgels Rev-01.jpg | |
| Data code | Code 128 | OTCXXXX | Aspire Mucus and Pain Relief Softgels Rev-01.jpg |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 81013-105-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7426-d83d-e063-dadaa90ab31f | dbc83501-9401-2a8d-e053-2a95a90a45c5 |
Products#
Every source-derived product name is available through these pages.
- Aspire Mucus and Pain Relief Softgels
- PROPYLENE GLYCOL
- POVIDONE K30
- GELATIN, UNSPECIFIED
- WATER
- FD&C BLUE NO. 1
- TITANIUM DIOXIDE
- LIGHT MINERAL OIL
- SORBITOL
- POLYETHYLENE GLYCOL 400
- GLYCERIN
- ACETAMINOPHEN
- GUAIFENESIN
- LECITHIN, SUNFLOWER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81013-105 | 81013-105-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| WATER | 059QF0KO0R | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| SORBITOL | 506T60A25R | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| LECITHIN, SUNFLOWER | 834K0WOS5G | 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 |
|---|---|---|---|---|---|---|
| f43ab341-0829-b18c-e053-2995a90ac22b | dbc83501-9401-2a8d-e053-2a95a90a45c5 | 2023-02-08 | Warnings | f43ab341-0829-b18c-e053-2995a90ac22b dbc83501-9401-2a8d-e053-2a95a90a45c5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
