ORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]

ORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]
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NDC 53943-501-28
Set ID e243033b-6603-4c3e-a330-e7c7de51f69d
Category HUMAN OTC DRUG LABEL
Packager Discount Drug Mart
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • Drug FactsActive ingredients (in each 30 mL dose cup)

    Acetaminophen 650 mg

    Dextromethorphan HBr 30 mg

    Doxylamine Succinate 12.5 mg

  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • Keep out of reach of children

    Keep out of reach of children.

  • Uses

    temporarily relieves cold/flu symptoms

    • sore throat
    • headache
    • minor aches and pain
    • fever
    • runny nose and sneezing
    • cough due to minor throat and bronchial irritation
  • WARNINGS

    DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKEN

    Failure to follow these warnings could result in serious consequences.

    Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage
    may occur if adult/child takes: ● 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 everyday while using this product.
    Allery Alert: Acetaminophen may cause severe skin reactions.
    Symptoms may include: ● skin reddening ● blisters ● rash
    If 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 monamine 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.
    • to make a child sleepy
  • Ask a doctor before use if you have

    • a sodium restricted diet
    • liver disease
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
    • trouble urinating due to enlarged prostate gland.
  • Ask a doctor or pharmacist before use

    • if you are taking sedatives or tranquilizers
    • if you are taking the blood thinning drug warfarin
  • When using this product

    • do not use more than directed
    • avoid alcoholic drinks
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness
  • Stop use and ask a doctor if

    • redness or swelling is present
    • symptoms do not get better within 7 days or are accompanied by a fever
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Overdose warning:

    Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help, or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms

  • Directions

    • take only as recommended-see Overdose warning
    • Use dose cup or tablespoon (TBSP)
    • do not exceed 4 doses per 24 hours
    • if taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours.
     adults and children 12 years and over 30 mL (2 TBSP) every 6 hours
     children 4 to under 12 years ask a doctor
     children under 4 years do not use

  • Other information

    • each 30 mL dose cup contains: sodium 45 mg
    • store at room temperature
  • Inactive ingredients

    citric acid, D and C yellow # 10, FD and C Green No. 3, FD and C Yellow No. 6,  flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

  • Questions?

    Call weekdays 1-877-798-5944

  • DISCOUNT drug mart FOOD FAIR Original Night-Time Multi-Symptom Cold/Flu Relief product label

    501-28 Lbl

    *COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® NYQUIL®

    DISCOUNT

    drug mart

    FOOD FAIR

    Original

    Night-Time Multi-Symptom Cold/Flu Relief

    Acetaminophen ...... Pain Reliever/Fever Reducer

    Dextromethorphan HBR ....... Cough Suppressant

    Doxylamine Succinate ........... Antihistamine

    12 FL OZ (354 mL)

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

    LR-065 REV  01

    SATISFACTION GUARANTEED

    IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256

  • INGREDIENTS AND APPEARANCE
    ORIGINAL NIGHT-TIME  MULTI-SYMPTOM COLD/FLU RELIEF
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-501
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-501-28354 mL in 1 BOTTLE; Type 0: Not a Combination Product10/21/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/21/2014
    Labeler - Discount Drug Mart (047741335)

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