Label: ANTIFLU DES COUGH AND FLU- acetaminophen phenylephrine hcl chlorpheniramine maleate capsule

  • NDC Code(s): 82688-001-12
  • Packager: Productos Farmaceuticos, S.A. de C.V.
  • 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 April 18, 2022

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

  • Active Ingredients

    Acetaminophen 325 mg

    Phenylephrine HCl 10 mg

    Chlorpheniramine Maleate 4 mg

  • Purpose

    Pain reliever/fever reducer

    Nasal decongestant

    Antihistamine

  • Uses

    Temporarily relieves common cold and flu symptoms: ▪sore throat ▪headache ▪minor aches and pains ▪fever ▪stuffy/runny nose and sneezing

  • Warnings

    Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ▪More than 4,000 mg 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 or severe allergic reactions. Symptoms can include▪ skin reddening ▪ blisters ▪ rash ▪ hives ▪ facial swelling ▪ asthma (wheezing) ▪ shock. If a skin or any allergic reaction occurs, stop use and seek medical attention right away.

    Sore throat warning: Severe or persistent sore throat lasting more than 2 days or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a Doctor promptly.

  • 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. If you are now taking a prescription Monoamine Oxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or if you have taken these products 2 weeks previously. If you do not know if your prescription drug contains an MAOI, ask a Doctor before taking this product

  • Ask a Doctor before use if you have

    ▪ Liver disease ▪ Heart disease ▪ High blood pressure ▪ Thyroid disease ▪ Diabetes ▪Glaucoma ▪ Breathing problem due to any given cause (asthma, chronic bronchitis or emphysema) ▪ Trouble urinating due to an enlarged prostate gland

  • Ask a Doctor before use if you are

    ▪Taking sedatives or tranquilizers ▪Taking the blood thinning drug warfarin

  • When using this product

    ▪ Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a Doctor. ▪ Do not mix with alcohol, sedatives and tranquilizers as they may increase drowsiness ▪ Driving a motor vehicle or operating machinery could be affected ▪ Excitability may occur especially in children(12-18 y) ▪ if symptoms do not improve within 7 days or are accompanied by fever, consult a Doctor

  • Stop use and ask a Doctor if

    ▪ Pain, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) ▪ Fever gets worse or last more than 3 days ▪ Redness or swelling is present ▪ New symptoms occur

  • Keep out of reach of children

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

    As with all medical products keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    ▪ Do not take more than recommended dose Adults and children 12 years of age and over: take 1 capsule with water every 4 hours. ▪ Do not exceed 6 capsules in 24 hours Children under 12 years of age: do not use

  • Other information

    Do not store above 77ºF(25ºC) and in a dry place

  • Inactive Ingredients

    Colloidal Silcon Dioxide, D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, FD&C Blue No. 1, Gelatin, Lactose Monohdyrate, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Shellac, Synthetic Iron Oxide, Titanium Dioxide

  • Questions and Comments?

    You may report any side effects to 1-305-677-0850 Monday through Sunday 24 hrs

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    ANTIFLU DES  COUGH AND FLU
    acetaminophen phenylephrine hcl chlorpheniramine maleate capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82688-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GELATIN (UNII: 2G86QN327L)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHELLAC (UNII: 46N107B71O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorgray (gray and orange) Scoreno score
    ShapeCAPSULE (immediate release hard gelatin) Size24mm
    FlavorImprint Code ANTIDESFLU
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82688-001-121 in 1 CARTON04/15/2022
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/15/2022
    Labeler - Productos Farmaceuticos, S.A. de C.V. (815664461)
    Establishment
    NameAddressID/FEIBusiness Operations
    Productos Farmaceuticos, S.A. de C.V.815664461manufacture(82688-001)