FDA Label for Algidol Flu

View Indications, Usage & Precautions

Algidol Flu Product Label

The following document was submitted to the FDA by the labeler of this product Gelpharma S.a. De C.v.. 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.

Active Ingredients (In Each Softgel Capsule)



Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg


Purpose



Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant


Uses



  • temporarily relieves
  • minor aches and pains associated with the common cold, sore throat, or headache
  • cough associated with the common cold
  • nasal congestion due to the common cold
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves
    • minor aches and pains associated with the common cold, sore throat, or headache
    • cough associated with the common cold
    • nasal congestion due to the common cold
    • runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever
    • temporarily reduces fever

Warnings



Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 capsules in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day 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.

      Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

      • more than 8 capsules in 24 hours, which is the maximum daily amount
      • with other drugs containing acetaminophen
      • 3 or more alcoholic drinks every day 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.


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.
  • for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
    • 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.
    • for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
    • if you have heart disease, high blood pressure, thyroid disease, diabetes, a breathing problem such as emphysema or chronic bronchitis, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Ask A Doctor Before Use If



you have liver disease.

you have liver disease.


Ask A Doctor Or Pharmacist Before Use



if you are taking the blood thinning drug warfarin.


When Using This Product



  • do not exceed the recommended dosage
  • do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. If pain or fever persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.
  • 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.
  • if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
    • do not exceed the recommended dosage
    • do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. because these could be signs of a serious condition.
    • 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.
    • if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
    • may cause excitability especially in children
    • may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

Stop Use And Ask A Doctor If



  • pain or nasal decongestion 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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
  • if nervousness, dizziness, or sleeplessness occur
    • pain or nasal decongestion 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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
    • if nervousness, dizziness, or sleeplessness occur

If Pregnant Or Breast-Feeding,



ask a health professional before use.

ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.


Directions



  • take only as directed
  • do not exceed 8 capsules per 24 hours
  •  Adults & children 12 years & over 2 capsules with water every 4 hours
     Children 4 to under 12 years Consult a doctor
     Children under 4 years Do not use

    • take only as directed
    • do not exceed 8 capsules per 24 hours
    •  Adults & children 12 years & over 2 capsules with water every 4 hours
       Children 4 to under 12 years Consult a doctor
       Children under 4 years Do not use


Other Information



  • do not exceed 77°F (25°C)
  • avoid excessive heat
    • do not exceed 77°F (25°C)
    • avoid excessive heat

Inactive Ingredients



gelatin, purified water, glycerin, polyethylene glycol 1000, propylene glycol, polyethylene glycol 600, povidone K30, orange flavor, FD&C Yellow No. 6, BHT, BHA.

gelatin, purified water, polyethylene glycol 1000, glycerin, polyethylene glycol 600, propylene glycol, povidone K30, citric acid, mint flavor, FD&C Blue No. 1, FD&C Yellow No. 6, BHT, BHA.


Ask A Doctor Or Pharmacist Before Use If



you are taking the blood thinning drug warfarin.


* Please review the disclaimer below.