REXALL NIGHT TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP INC]

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  • REXALL NIGHT TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP INC]

REXALL NIGHT TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP INC]
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NDC 55910-872-34, 55910-872-38
Set ID fea2d6c6-d448-495e-8401-5eac6cddeb73
Category HUMAN OTC DRUG LABEL
Packager Dolgencorp Inc
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
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  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 12.5 mg

  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • Uses

    temporarily relieves common cold/flu symptoms:

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

    •
    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
    •
    glaucoma
    •
    cough that occurs with too much phlegm (mucus)
    •
    a breathing problem such as emphysema or chronic bronchitis
    •
    trouble urinating due to an enlarged prostate gland
    •
    persistent or chronic cough as occurs with smoking, asthma, or emphysema
    •
    a sodium-restricted diet
  • Ask a doctor or pharmacist before use if you are

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

    •
    excitability may occur, especially in children
    •
    marked drowsiness may occur
    •
    avoid alcoholic drinks
    •
    be careful when driving a motor vehicle or operating machinery
    •
    alcohol, sedatives, and tranquilizers may increase drowsiness
  • Stop use and ask a doctor if

    •
    pain 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.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 Overdose warning
    •
    only use the dose cup provided
    •
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use
  • Other information

    •
    each 30 mL contains: sodium 39 mg
    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • Package/Label Principal Display Panel

    NightTime Cold & Flu

    Multi-Symptom Relief

    Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

    Acetaminophen – Aches, fever

    Dextromethorphan HBr – Cough

    Doxylamine succinate – Sneezing, runny nose

    SEE NEW WARNINGS

    Mixed Berry FLAVOR

    GLUTEN FREE

    8 FL OZ (237 mL)

    10% ALCOHOL

    872-cf-nighttime-cold-&flu.jpg
  • INGREDIENTS AND APPEARANCE
    REXALL NIGHT TIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, doxylamine succinate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-872
    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
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorRED (clear dark red) Score    
    ShapeSize
    FlavorBERRY (berry/fruity) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-872-38296 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2012
    2NDC:55910-872-34237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/03/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/09/2012
    Labeler - Dolgencorp Inc (068331990)
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