Label: CONRX NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 11, 2014

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each Caplet)Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 15 mgCough suppressant
    Dexylamine succinate 6.25 mgAntihistamine
  • 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 doses in 24 hrs, 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure wheather a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are now taking 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.
    • to make a child 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

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers.
    • taking the blood thinning drug warfarin

    When using this product

    • do not use more than directed
    • 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

    Taking more than directed 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 & for children even if you do not notice any signs or symptoms.

  • Directions

    • take only as directed - see Overdose warning
    • do no exceed 4 doses per 24 hours

    adult and children 12 years and over, 2 Caplets 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
  • Inactive ingredients

    cross carmellose sodium, D&C Yellow No.10, FD&C Blue No.1, cellulose microcrystalline, polysorbate 80, silicone dioxide, talc, titanium dioxide, corn starch, gelatin, magnesium stearate, sodium starch glycolate, sodium benzoate, hydroxy propyl methyl

  • Questions?

    1-855-619-7900

  • PRINCIPAL DISPLAY PANEL - 50 x 2 Caplet Pouch Box

    Compare to the Active Ingredients in
    NyQuil®

    ConRx® NightTime
    COLD & FLU
    NightTime Relief

    Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

    Aches, Fever & Sore Throat
    Sneezing, Runny Nose
    Cough

    2 Caplets Each Pouch

    TO OPEN
    PUSH IN TAB AND PULL OUT

    Compare to the Active Ingredients in
    NyQuil®

    2 Caplets Each Pouch

    Principal Display Panel - 50 x 2 Caplet Pouch Box
  • INGREDIENTS AND APPEARANCE
    CONRX NIGHTTIME 
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68737-239
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    Product Characteristics
    ColorGREENScore2 pieces
    ShapeOVALSize18mm
    FlavorImprint Code CRX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68737-239-2350 in 1 BOX
    12 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/10/2014
    Labeler - Eagle Distributors,Inc. (929837425)