DAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI) CAPSULE, LIQUID FILLED [A&Z HOLISTIC PRODUCTS, INC.]

DAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI) CAPSULE, LIQUID FILLED [A&Z HOLISTIC PRODUCTS, INC.]
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NDC 69619-303-10
Set ID f78fdf84-5ed2-49ce-bc9b-e31663bdc92a
Category HUMAN OTC DRUG LABEL
Packager A&Z Holistic Products, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENTS (IN EACH SOFTGEL)

    Acetaminophen 325mg

    Dextromethorphan HBr 10mg

    Phenylephrine HCI 5mg

  • PURPOSES

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • USES

    temporarily relieves common cold and fly symptoms:

    • nasal congestion
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains, fever
  • WARNINGS

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

    • more than 4 doses in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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 product 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 drugs. If you do not know if your prescription contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • thyroid disease
    • diabetes
    • high blood pressure
    • trouble urinating due to enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough as occurs with smoking, asthma, or emphysema

    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

    • you get nervous, dizzy or sleepless
    • symptoms get worse or last more than 5 days (children) or 7 days (adults)
    • 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

    Overdose warning: In case of accidental overdose, contact a doctor or Poison Control Center immediately (1-800-222-1222). Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

  • DIRECTIONS

    • take only as directed (see Warnings)
    • do not exceed 4 doses per 24 hours

    Adults and children 12 years and over

    • take 2 softgels with water every 4 hours

    Children 4 to under 12 years

    • Ask a doctor

    Children under 4 years

    • Do not use
  • OTHER INFORMATION

    • store at room temperature
    • do not use if blister is torn or open
  • INACTIVE INGREDIENTS

    FD&C Red #40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol, FD&C Yellow #6.

  • QUESTIONS OR COMMENTS?

    Call toll free 1-844-374-0016

  • PRINCIPAL DISPLAY PANEL

    Product Label

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® Dayquil® Cold & Flu Liquicaps

    Manufactured for:

    AZ Holistic Products, Inc.

    Hauppauge, NY 11788

    Label

  • INGREDIENTS AND APPEARANCE
    DAYTIME COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hbr, phenylephrine hci capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69619-303
    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
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Colororange (amber) Scoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 534
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69619-303-101 in 1 BOX03/24/2016
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/24/2016
    Labeler - A&Z Holistic Products, Inc. (079721290)
    Registrant - A&Z Holistic Products, Inc. (079721290)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anshi Pharmaceutical (Zhongshan) Inc.528101821manufacture(69619-303)

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