Home > Drugs A-Z > ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE (SPIRIT PHARMACEUTICALS, LLC)

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 4 CAPSULE, LIQUID FILLED in 1 BOX (68210-0102-1) Label Information
CAPSULE, LIQUID FILLED 5000 CAPSULE, LIQUID FILLED in 1 BOX (68210-0102-4) Label Information
CAPSULE, LIQUID FILLED 2500 CAPSULE, LIQUID FILLED in 1 BOX (68210-0102-6) Label Information
CAPSULE, LIQUID FILLED 100 CAPSULE, LIQUID FILLED in 1 BOX (68210-0102-2) Label Information
CAPSULE, LIQUID FILLED 10000 CAPSULE, LIQUID FILLED in 1 BOX (68210-0102-5) Label Information
CAPSULE, LIQUID FILLED 1000 CAPSULE, LIQUID FILLED in 1 BOX (68210-0102-3) Label Information

Complete ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients (in each LiquiCap) Purpose
    Acetaminophen 325 mg Pain reliever/fever reducer
    Dextromethorphan HBr 15 mg Cough suppressant
    Doxylamine succinate 6.25 mg 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

    Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

    Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    • with other medicines containing acetaminophen
    • 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.

    Ask a doctor before use if you have

    • 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.

    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 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 for children even if you do not notice any signs or symptoms.


  • Directions

    • take only as recommended - see Overdose warning
    • do not exceed 4 doses per 24 hours
    adults and children 12 years and over 2 LiquiCaps with water every 6 hours
    children under 12 years ask a doctor
    • when using other DayQuil or NyQuil products, carefully read each label to insure correct dosing

  • Other information

    • store at room temperature

  • Inactive ingredients

    D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide


  • PRINCIPAL DISPLAY PANEL

    Acetaminophen, Dextromethorphan HBr & Doxylamine Succinate capsule

    Each Softgel Contains:
    (Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 15 mg,
    Doxylamine Succinate USP 6.25mg)

    LOT NO:
    DRUM NO:
    MFG DATE:
    QUANTITY:
    NDC NO: 68210-0102-
    EXP DATE:

    WARNING:
    KEEP OUT OF REACH OF CHILDREN

    STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
    PROTECT FROM LIGHT, MOISTURE AND FREEZING

    THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
    CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
    THE F.D & C.ACT AND REGULATIONS THEREUNDER.

    MANUFACTURED BY:
    SOFTGEL HEALTHCARE PVT LIMITED
    INDIA
    LABELLER CODE: 35916
    LIC NO.: TN/DRUGS/00002124

    MANUFACTURED FOR:
    SPIRIT PHARMACEUTICALS LLC
    225 LINCOLN HWY, STE 205
    FAIRLESS HILLS, PA 19030
    PH.# 215 943 4000
    FAX.# 215 943 4039

    CAUTION: "FOR MANUFACTURING, PROCESSING OR REPACKING"

    • 1 – 4
    • 2 – 100
    • 3 – 1000
    • 4 – 5000
    • 5 – 10000
      6 - 2500
    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE 
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0102
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    Color GREEN Score no score
    Shape OVAL Size 20mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68210-0102-1 4 in 1 BOX
    2 NDC:68210-0102-2 100 in 1 BOX
    3 NDC:68210-0102-3 1000 in 1 BOX
    4 NDC:68210-0102-4 5000 in 1 BOX
    5 NDC:68210-0102-5 10000 in 1 BOX
    6 NDC:68210-0102-6 2500 in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 10/15/2009
    Labeler - SPIRIT PHARMACEUTICALS, LLC (179621011)