FDA Label for Aspire Congestion And Cough Relief Dm Softgels
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- WARNINGS AND PRECAUTIONS
- 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
- WARNINGS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Aspire Congestion And Cough Relief Dm 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
Dextromethorphan HBr 10 mg – Cough Suppressant
Guaifenesin 200 mg - Expectorant
Dosage & Administration
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
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
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.
- Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- Cough that occurs with too much phlegm (mucus)
- 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.
Ask a doctor before use if you have
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.
Inactive Ingredient
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
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
Ask a doctor or pharmacist before use if your prescription drug contains and MAOI
Otc - Do Not Use
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
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
Guaifenesin 200 mg -Expectorant
Dextromethorphan HBr 10 mg -Cough suppressant
Otc - Questions
1-732-447-1444
Otc - Stop Use
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
When using this product do not use more than directed
Warnings
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.
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
- 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.
Ask a doctor before use if you have
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.
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