COLD AND FLU NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WAL-MART STORES INC]

COLD AND FLU NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WAL-MART STORES INC]
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NDC 49035-659-22, 49035-659-42
Set ID 19bbb06d-16ee-4bfe-8f3d-d52d6153fd5e
Category HUMAN OTC DRUG LABEL
Packager Wal-Mart Stores Inc
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients (in each liquid-filled capsule)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCl 5 mg 

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant 

  • Uses

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

    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
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • 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 
    • do not take more than 8 capsules per 24 hours
    • adults and children 12 years and over: take 2 capsules with water every 4 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)
    • protect from heat, humidity and light
    • see end flap for expiration date and lot number 
  • Inactive ingredients

    edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

  • Questions or comments?

    1-888-287-1915

  • Principal Display Panel

    NDC 49035-659-22

    equate

    Compare to Vicks® DayQuil® Cold & Flu LiquiCaps® Active Ingredients*

    Non-Drowsy
    DayTime
    Cold & Flu   

    Acetaminophen, Dextromethorphan HBr,
    Phenylephrine HCl

    Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant  
    Multi-Symptom Relief

    • Aches, fever
    • Cough
    • Nasal congestion

    Alcohol Free and Antihistamine Free

    48 CAPSULES

    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 or to report an undesired reaction or side effect, please call 1-888-287-1915.

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

    PRODUCT OF CHINA.
    Packaged and Quality Assured in the United States.
    *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® Cold & Flu LiquiCaps®.

    50844    REV0216A65922

    Equate 44-659

    Equate 44-659


  • INGREDIENTS AND APPEARANCE
    COLD AND FLU  NON-DROWSY, DAYTIME
    acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-659
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colororange (clear) Scoreno score
    ShapeOVALSize21mm
    FlavorImprint Code 659
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-659-224 in 1 CARTON03/01/2015
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49035-659-4212 in 1 BLISTER PACK; Type 0: Not a Combination Product03/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2015
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(49035-659)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(49035-659)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(49035-659)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(49035-659)

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