Label: COLD AND FLU SEVERE- acetaminophen,dextromethorphan hbr,guaifenesin,phenylephrine hcl tablet, film coated

  • NDC Code(s): 49035-053-08, 49035-053-42
  • Packager: Wal-Mart Stores Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 4, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredients (in each caplet)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • Uses

    • temporarily relieves these common cold and flu symptoms:
      • sore throat
      • cough
      • nasal congestion
      • headache
      • minor aches and pains
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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

    • 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    • heart disease
    • liver disease
    • diabetes
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • thyroid disease
    • cough that occurs with too much phlegm (mucus)
    • difficulty in urination due to enlargement of the prostate gland
    • high blood pressure

    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 occur
    • pain, nasal congestion, or cough gets worse or lasts more than 7 days
    • new symptoms occur
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    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 for children even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed
    • adults and children 12 years and over
      • take 2 caplets every 4 hours
      • swallow whole - do not crush, chew, or dissolve
      • do not take more than 10 caplets in 24 hours
    • children under 12 years: ask a doctor
  • Other information

    • each caplet contains: sodium 3 mg
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

  • Questions or comments?

    1-888-287-1915

  • Principal display panel

    equate

    NDC 49035-053-08

    Compare
    to Tylenol®
    COLD + FLU SEVERE
    active
    ingredients*

    Severe
    Cold & Flu

    Acetaminophen - Pain Reliever/
    Fever Reducer
    Dextromethorphan HBr - Cough Suppressant
    Guaifenesin - Expectorant
    Phenylephrine HCl - Nasal Decongestant

    Relieves:
    • Headache & body aches
    • Fever & sore throat
    • Cough
    • Nasal congestion
    • Mucus & chest congestion

    24
    CAPLETS

    Actual Size

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
    OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR
    SHOWS ANY SIGNS OF TAMPERING

    Satisfaction guaranteed - For questions or comments please call 1-888-287-1915.

    DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

    *This product is not manufactured or distributed by
    Johnson & Johnson Corporation, owner of the registered
    trademark Tylenol® COLD + FLU SEVERE.
    50844                                                                                        REV0922C50308

    PARENTS:
    Learn about teen medicine abuse
    www.StopMedicineAbuse.org

    Equate 44-503A

    Equate 44-503A

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU  SEVERE
    acetaminophen,dextromethorphan hbr,guaifenesin,phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-053
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize19mm
    FlavorMENTHOLImprint Code 44;503
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-053-082 in 1 CARTON08/04/2005
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49035-053-4212 in 1 BLISTER PACK; Type 0: Not a Combination Product08/04/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/04/2005
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(49035-053) , pack(49035-053)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(49035-053)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(49035-053)