FDA Label for Aspire Mucus And Pain Relief Softgels
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- WARNINGS
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - DO NOT USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - PURPOSE
- OTC - QUESTIONS
- OTC - STOP USE
- OTC - WHEN USING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Aspire Mucus And Pain Relief Softgels Product Label
The following document was submitted to the FDA by the labeler of this product Aspire Pharmaceuticals Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients (in each liquid gel) Purposes
Acetaminophen 325 mg - Pain reliever/fever reducer
Guaifenesin 200 mg - Expectorant
Dosage & Administration
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
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
- skin reddening
- blisters
- rash
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- liver disease
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
- 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.
Allergy alert
Acetaminophen may cause severe skin reactions. Symptoms may include:
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
Ask a doctor before use if you have
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
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
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
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
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
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - Do Not Use
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
Keep out of reach of children
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Purpose
Active Ingredient Purpose
Acetaminophen 325 mg - Pain reliever/fever reduce
Guaifenesin 200 mg -Expectorant
Otc - Questions
1-732-447-1444
Otc - Stop Use
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
When using this product do not use more than directed
* Please review the disclaimer below.