Label: ACETAFLU DAYTIME- acetaminophen, dextromethorphan hbr, phenylephrine hcl powder

  • NDC Code(s): 13411-838-06
  • 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 March 26, 2020

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

  • ACTIVE INGREDIENT

    Active ingredients (in each packet)                                                                   Purposes

    Acetaminophen 650 mg.............................................................................Pain reliever/fever reducer
    Dextromethorphan hydrobromide 20 mg.....................................................Cough suppressant
    Phenylephrine hydrochloride 10 mg............................................................Nasal decongestant

  • PURPOSE

  • INDICATIONS & USAGE

    Uses
    • temporarily relieves these symptoms due to a cold:
    • minor aches and pains • minor sore throat pain • headache
    • nasal and sinus congestion • cough due to minor throat and bronchial irritation
    •temporarily reduces fever

  • WARNINGS

    Warnings
    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
    • more than 6 packets 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
    Sore throat warning: 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.

    Do not use • in a child under 12 years of age • if you are allergic to acetaminophen
    • 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.

    Ask a doctor before use if you have
    • liver disease • heart disease • high blood pressure • thyroid disease • diabetes
    • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

    Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin

    When using this product • do not exceed recommended dosage

    Stop use and ask a doctor if
    • nervousness, dizziness, or sleeplessness occurs • fever gets worse or lasts more than 3 days
    • redness or swelling is present • new symptoms occur • symptoms do not get better or worsen
    • pain, cough or nasal congestion gets worse or lasts more than 7 days
    • cough comes back or occurs with fever, rash or headache that lasts. These could be signs or serious condition.

    If pregnant or breast-feeding, ask a health care professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use more than directed
    • take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor

    Age Dose

    children under 4 years of age                                     do not use
    children 4 to under 12 years of age                            do not use unless directed by a doctor
    adults and children 12 years of age and over               one packet

    • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 – 15 minutes.

    • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating.
    Do not overheat.

  • SPL UNCLASSIFIED SECTION

    Other information
    • each packet contains: sodium 20 mg
    • store at controlled room temperature 20-25ºC (68-77ºF). Protect from excessive heat and moisture.

  • INACTIVE INGREDIENT

    Inactive ingredients

    sodium citrate, mannitol, aspartame, hydroxypropyl cellulose, citric acid, tween 80, acesulfame potassium, flavors, sodium bicarbonate

  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    ACETAFLU DAYTIME 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13411-838
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 2 g
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE25 mg  in 2 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    MANNITOL (UNII: 3OWL53L36A)  
    ASPARTAME (UNII: Z0H242BBR1)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13411-838-066 in 1 BOX03/24/2020
    12 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/24/2020
    Labeler - Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals (187498279)
    Establishment
    NameAddressID/FEIBusiness Operations
    S.P.M CORPORATION555279715manufacture(13411-838)