Acetaflu Cough And Chest Congestion
FDA Label NDC 13411-852

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals for the product Acetaflu Cough And Chest Congestion (NDC 13411-852). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purposes, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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