Label: COLD MULTI-SYMPTOM DAYTIME- acetaminophen, dextromethorphan hbr, and phenylephrine hcl tablet

  • NDC Code(s): 49035-560-08, 49035-560-42
  • Packager: Wal-Mart Stores Inc
  • 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 October 1, 2020

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

  • Active ingredients (in each gelcap)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant

  • Uses

    • temporarily relieves these common cold and flu symptoms:
      • headache
      • cough
      • sinus congestion and pressure
      • nasal congestion
      • sore throat
      • minor aches and pains
    • helps clear nasal passages
    • promotes nasal and sinus drainage
    • 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
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • high blood pressure
    • thyroid disease
    • difficulty in urination due to enlargement of the prostate gland
    • cough that occurs with too much phlegm (mucus)

    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
    • persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache

    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 gelcaps every 4 hours
      • do not take more than 10 gelcaps 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) 
    • avoid high humidity
    • see end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, crospovidone, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silica gel, stearic acid, titanium dioxide

  • Questions or comments?

    1-888-287-1915

  • Principal Display Panel

    NDC 49035-560-08

    equate™

    Compare to Tylenol® COLD MAX Day Active Ingredients*

    Rapid Release
    Cold
    Multi-Symptom
    Acetaminophen,
    Dextromethorphan HBr,
    Phenylephrine HCl

    Pain Reliever, Fever Reducer,
    Cough Suppressant, Nasal Decongestant

    Daytime Non-Drowsy

    • Headache, fever, sore throat
    • Nasal congestion
    • Cough

    24
    GELCAPS

    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-Or we'll replace it or give you your money back. For questions or comments, please call 1-888-287-1915.

    DISTRIBUTED BY: Wal-Mart Stores, Inc.,
    Bentonville, AR 72716 

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® COLD MAX Day.
    50844      REV0216A56008

    Equate 44-560

    Equate 44-560

  • INGREDIENTS AND APPEARANCE
    COLD MULTI-SYMPTOM  DAYTIME
    acetaminophen, dextromethorphan hbr, and phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-560
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    ColorRED, PURPLEScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code L;0
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-560-082 in 1 CARTON03/29/200806/26/2023
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49035-560-4212 in 1 BLISTER PACK; Type 0: Not a Combination Product03/29/200806/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/29/200806/26/2023
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(49035-560)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(49035-560)