DAY TIME MULTI-SYMPTOM FLU COLD MEDICINE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [SALADO SALES, INC.]

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  • DAY TIME MULTI-SYMPTOM FLU COLD MEDICINE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [SALADO SALES, INC.]

DAY TIME MULTI-SYMPTOM FLU COLD MEDICINE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [SALADO SALES, INC.]
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NDC 57243-659-02
Set ID 401ad072-7e05-41bf-97e2-dbcecb82ff8e
Category HUMAN OTC DRUG LABEL
Packager Salado Sales, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • 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:
      • sore throat
      • minor aches and pains
      • headache
      • 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 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

    • 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
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    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
    • 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
    • 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

    • protect from heat, humidity and light
    • 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

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

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

     CVP®
    HEALTH

    COMPARE TO VICKS® DAYQUIL® COLD & FLU LIQUICAPS® ACTIVE INGREDIENTS*

    DAY TIME
    LIQUID CAPS

    MULTI-SYMPTOM FLU & COLD MEDICINE

    • ACETAMINOPHEN - PAIN RELIEVER/FEVER REDUCER
    • DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT
    • PHENYLEPHRINE HCl - NASAL DECONGESTANT

    12 LIQUID CAPS
    ALCOHOL & ANTIHISTAMINE FREE

    RELIEVES:
    ACHES & PAINS
    SORE THROAT
    COUGH
    STUFFY HEAD
    FEVER SYMPTOMS
    ASSOCIATED WITH THE
    COMMON COLD & FLU

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

    *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Vicks® DayQuil® Cold & Flu LiquiCaps®.

    50844         REV0418C65902

    Distributed by Consumer Value Products, Inc.
    P.O. Box 6115, Temple, Texas 76502
    CVPproducts.com

    Product of China
    Packaged and Quality Assured in the USA

    44-659

    44-659

  • INGREDIENTS AND APPEARANCE
    DAY TIME  MULTI-SYMPTOM FLU COLD MEDICINE
    acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-659
    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)  
    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:57243-659-021 in 1 CARTON03/01/2015
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/01/2015
    Labeler - Salado Sales, Inc. (009830555)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(57243-659)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(57243-659)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(57243-659)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(57243-659)
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