Home > Drugs A-Z > Daytime Multi-Symptom Severe Cold

Daytime Multi-Symptom Severe Cold (WALGREEN CO.)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 2 BLISTER PACK in 1 CARTON (0363-0503-08) > 12 TABLET, COATED in 1 BLISTER PACK Label Information

Complete Daytime Multi-Symptom Severe Cold Information

  • 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:
      • headache
      • minor aches and pains
      • sore throat
      • nasal congestion
      • cough
    • 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 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 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
    • liver disease
    • diabetes
    • heart disease
    • high blood pressure
    • thyroid disease
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)

    Ask a doctor or pharmacist before use if 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 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 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

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • 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, silicone dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide


  • Questions or comments?

    1-800-426-9391


  • Principal Display Panel

    Well at
    Walgreens

    WALGREENS PHARMACIST RECOMMENDED‡

    NDC 0363-0503-08

    DAYTIME
    MULTI-SYMPTOM
    NON-DROWSY

    Severe
    Cold

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

     Fever/headache, sore throat, nasal congestion,
    cough & chest congestion

    24
    CAPLETS

    Actual Size

    Compare to Tylenol® Cold
    Multi-Symptom Severe
    active ingredients‡‡

    PSEUDOEPHEDRINE FREE  COOL BLAST FLAVOR

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

    Walgreens
    100% SATISFACTION
    GUARANTEED

    walgreens.com ©2016 Walgreen Co.

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

    ‡Walgreens Pharmacist Survey Study, November 2014.

    ‡‡This product is not manufactured or distributed by McNeil
    Consumer Healthcare, owner of the registered trademark Tylenol®
    Cold Multi-Symptom Severe.   50844   REV0316A50308

    Walgreens 44-503A

    Walgreens 44-503A




  • INGREDIENTS AND APPEARANCE
    SEVERE COLD  DAYTIME MULTI-SYMPTOM NON-DROWSY
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0503
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color YELLOW Score no score
    Shape OVAL Size 19mm
    Flavor MINT Imprint Code 44;503
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0503-08 2 in 1 CARTON 08/04/2005
    1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:0363-0503-07 3 in 1 CARTON 08/04/2005
    2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 08/04/2005
    Labeler - Walgreen Company (008965063)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(0363-0503)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(0363-0503)