Label: ACETAFLU COUGH AND CHEST CONGESTION- dextromethorphan hbr,guaifenesin powder

  • NDC Code(s): 13411-852-06, 13411-852-12, 13411-852-20
  • Packager: Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 31, 2020

If you are a consumer or patient please visit this version.

  • 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

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ACETAFLU COUGH AND CHEST CONGESTION 
    dextromethorphan hbr,guaifenesin powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13411-852
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 g
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13411-852-066 in 1 BOX08/31/2020
    15 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:13411-852-1212 in 1 BOX08/31/2020
    25 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:13411-852-2020 in 1 BOX08/31/2020
    35 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/31/2020
    Labeler - Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals (187498279)
    Establishment
    NameAddressID/FEIBusiness Operations
    S.P.M CORPORATION555279715manufacture(13411-852)