NIGHT TIME COLD AND FLUE RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]

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  • NIGHT TIME COLD AND FLUE RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]

NIGHT TIME COLD AND FLUE RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]
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NDC 69168-357-29, 69168-357-51
Set ID b54b14df-886e-438f-8b63-bbc5376fd653
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
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  • Active ingredient (in each softgel)

    Acetaminophen 325 mg
    Dextromethorphan HBr 15 mg
    Doxylamine succinate 6.25 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Antihistamine

  • Uses

    temporarily relieves common cold and 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 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
    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 products 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 drug contains an MAOI, ask a doctor or pharmacist before taking this product    ■ to put a child to sleep

    Ask a doctor before use if you have

    ■ 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

    When using this product

    ■ do not exceed recommended dosage   ■ 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 last 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, contact a doctor or Poison Control Center immediately (1-800-222-1222). Taking more than the recommended dose can cause serious health problems. 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 recommended (see Warnings)   ■ do not exceed 4 doses per 24 hours
    ■ Adults and children 12 years and over: ■ take 2 softgels with water every 6 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 blue #1, FD&C yellow #10, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

  • Package/Label Principal Display Panel

    Health A2Z 357

    Health A2Z 357

  • INGREDIENTS AND APPEARANCE
    NIGHT TIME COLD AND FLUE RELIEF 
    acetaminophen, dextromethorphan, doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-357
    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 HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-357-298 in 1 BOX; Type 0: Not a Combination Product03/03/2015
    2NDC:69168-357-5120 in 1 BOX; Type 0: Not a Combination Product03/03/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/03/2015
    Labeler - Allegiant Health (079501930)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930ANALYSIS(69168-357) , LABEL(69168-357) , MANUFACTURE(69168-357) , PACK(69168-357)
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