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DAY-TIME (DeMoulas Market Basket)

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LIQUID 354 mL in 1 BOTTLE (53942-506-28) Label Information

Complete DAY-TIME Information

  • Drug Facts Active Ingredients (in each 15 mL, 1 tablespoon)


    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCL 5 mg


  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant


  • Keep out of reach of children

    Keep this and all drugs out of the reach of children.


  • Uses

    Uses

    temporarily relieves these common cold/flu symptoms:

    • minor aches and pains
    • headache
    • sore throat
    • fever
    • nasal congestion
    • 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 doses 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 causesevere skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reactions occurs, stop 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

    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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product
    • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacists.

  • Ask a doctor before use if you have Ask a doctor or pharmacist

    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
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by excessive phlegm (mucus)

    Ask a doctor or pharmacist before use

    if the user is taking the blood thinning drug warfarin


  • When using this product

    • do not use more than directed (see overdose warning)
    • avoid alcoholic drinks

  • Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • new symptoms occur
    • fever gets worse or lasts more than 3 days
    • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
    • 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 of breast-feeding

    ask a health professional before use.


  • Overdose Warning

    Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


  • Directions

    Directions

    • take only as recommended (see overdose warning)
    • use dosage cup or tablespoon (TBSP)
    • do not exceed 4 doses per 24 hours



    age                                                                                                         dose
    adults and children 12 years and over                                                        30 mL (2 TBSP) every 4 hours
    children 6 years to under 12 years                                                             15 mL (1 TBSP) every 4 hours
    children 4 years to  under 6 years                                                              ask a doctor
    children under 4 years                                                                              do not use

    • When using Day Time and Night Time products, carefully read each label to ensure correct dosing.

  • Other information

    • sodium content per tablespoon: 10 mg
    • store at room temperature

  • Inactive ingredients

    citric acid, FD and C Yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucrose


  • Questions?

    Call weekdays from 9:30 AM to 4:30 PM EST at

    1-877-798-5944


  • Product Label

    MARKET BASKET ®

    “MORE FOR YOUR DOLLAR”

    *COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ®
    DAYQUIL ®

    DAY-TIME
    COLD AND FLU RELIEF

    Acetaminophen……Pain Reliever/Fever Reducer
    Dextromethorphan HBr……Cough Suppressant
    Phenylephrine HCL ……. Nasal Decongestant

    12 FL OZ (354 ML)

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
    Failure to follow these warnings could result in serious consequences

    *This product is not manufactured or distributed by Proctor and Gamble, owner of the registered trademark Vicks® Dayquil®.

    DISTRIBUTED BY DEMOULAS SUPERMARKETS INC.
    875 EAST STREET
    TEWKSBURY, MA 01876

    LR-036

    LOT:                EXP:

    AptaPharmMB DayTime 506


  • INGREDIENTS AND APPEARANCE
    DAY-TIME  COLD AND FLU
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53942-506
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53942-506-28 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 09/12/2012
    Labeler - DeMoulas Market Basket (007869647)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    Name Address ID/FEI Business Operations
    AptaPharma Inc. 790523323 manufacture(53942-506)