FDA Label for Aspire Day Congestion And Headache Softgel
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 Day Congestion And Headache Softgel 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
Dextromethorphan HBr 10 mg - Cough suppressant
Guaifenesin 200 mg - Expectorant
Phenylephrine HCl 5 mg - Nasal decongestant
Active ingredients in each liquid gel -Purposes
Acetaminophen 325 mg-Pain reliever/fever reducer
Dextromethorphan HBr 10 mg -Cough suppressant
Guaifenesin 200 mg - Expectorant
Phenylephrine HCl 5 mg-Nasal decongestant
Active ingredients (in each liquid gel) Purposes
Acetaminophen 325 mg -Pain reliever/fever reducer
Dextromethorphan HBr 10 mg -Cough suppressant
Phenylephrine HCl 5 mg -Nasal decongestant
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
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.
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.
- if you are now taking a prescription monoamine 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 an MAOI, ask a doctor or pharmacist before taking this product.
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, 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.
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
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:
- Temporarily reduces fever
- Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Nasal congestion
Headache
Cough
Minor aches and pains
Sore throat
Inactive Ingredient
INACTIVE INGREDIENTS
Polyethylene Glycol
Propylene Glycol
Povidone
Gelatin
Glycerin
Sorbitol Sorbitan Solution
Purified Water
FD&C Colors
Purified Water
Otc - Ask Doctor
Ask a doctor before use if you have
- Liver disease
- Heart disease
- Diabetes
- High blood pressure
- Thyroid disease
- Trouble urinating due to an enlarged prostate gland
- Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- Cough that occurs with too much phlegm (mucus)
- Liver disease
- Heart disease
- Diabetes
- High blood pressure
- Thyroid disease
- Glaucoma
- Trouble urinating due to an enlarged prostate gland
- Breathing problems such as emphysema or chronic bronchitis
- Cough that occurs with too much phlegm (mucus)
- Persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- Liver disease
- Heart disease
- Diabetes
- High blood pressure
- Thyroid disease
- Trouble urinating due to an enlarged prostate gland
- Persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- Cough that occurs with too much phlegm (mucus)
Ask a doctor before use if you have
Ask a doctor before use if you have
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you are
- Taking the blood thinning drug warfarin
- Taking sedatives or tranquilizers
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.
- If you are now taking a prescription monoamine 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 an MAOI, ask a doctor or pharmacist before taking this product.
- With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- If you are now taking a prescription monoamine 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 an MAOI, ask a doctor or pharmacist before taking this product.
- With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- If you are now taking a prescription monoamine 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 an MAOI, ask a doctor or pharmacist before taking this product.
Do not use
Do not use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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.
If pregnant or breast-feeding, ask a health professional before use.
If pregnant or breast-feeding, ask a health professional before use.
Otc - Purpose
Active Ingredient Purpose
Acetaminophen 325 mg -Pain reliever/fever reducer
Dextromethorphan HBr 10 mg -Cough suppressant
Guaifenesin 200 mg -Expectorant
Phenylephrine HCl 5 mg -Nasal decongestant
Active ingredients Purposes
Acetaminophen 325 mg -Pain reliever/fever reducer
Dextromethorphan HBr 10 mg -Cough suppressant
Doxylamine succinate 6.25 mg -Antihistamine
Phenylephrine HCl 5 mg -Nasal decongestan
Active ingredients (in each liquid gel) Purposes
Acetaminophen 325 mg -Pain reliever/fever reducer
Dextromethorphan HBr 10 mg -Cough suppressant
Phenylephrine HCl 5 mg -Nasal decongestant
Otc - Questions
1-732-447-1444
1-732-447-1444
1-732-447-1444
Otc - Stop Use
Stop use and ask a doctor if
- Nervousness, dizziness, or sleeplessness occur
- Pain, nasal congestion, 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.
- Nervousness, dizziness, or sleeplessness occur
- Pain, nasal congestion, 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.
- Nervousness, dizziness, or sleeplessness occur
- Pain, nasal congestion, 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.
Stop use and ask a doctor if
Stop use and ask a doctor if
Otc - When Using
When using this product do not use more than directed
When using this product do not use more than directed
Package Label.Principal Display Panel
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