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  5. Label Information: Acetaflu Cough And Chest Congestion

FDA Label for Acetaflu Cough And Chest Congestion

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN.
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS.

Acetaflu Cough And Chest Congestion Product Label

The following document was submitted to the FDA by the labeler of this product Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals. 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



Dextromethorphan HBr 20 mg

Guaifenesin 400 mg


Purposes



  • Cough suppressant
  • Expectorant

Uses



  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  •  helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings



Do not use

  •  in a child under 12 years of age
  •  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.

    • Ask a doctor before use if you have

    •  cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • a sodium-restricted diet

      • When using this product

      • do not exceed recommended dosage

        • 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.

          • If pregnant or breast-feeding,

          • ask a health care professional before use.

Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions




do not use more than directed
take every 4 hours. Do not take more than 6 packets in 24 hours.

AgeDose
adults and children 12 years of age and over  one packet
 children under 12 years of agedo not use 
  • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • if using microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. 
  • Do not overheat.

Other Information




  •  each packet contains: potassium 12 mg, sodium 51 mg.
  • store at controlled room temperature 20-25°C (68-77°F).

Inactive Ingredients.



acesulfame potassium, anhydrous citric acid, flavor, lactose, maltodextrin, mannitol, povidone K30, silicon dioxide, sodium bicarbonate, sodium chloride, sodium citrate, sucralose, sucrose


* Please review the disclaimer below.