Label: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE capsule, liquid filled

  • NDC Code(s): 35916-0189-1
  • Packager: SOFTGEL HEALTHCARE PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 4, 2025

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

  • Active Ingredients (in each capsule)

    Acetaminophen USP 325 mg
    Dextromethorphan HBr USP 10 mg
    Doxylamine Succinate USP 6.25 mg

  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to a cold or flu :

    • minor aches and pains • headache • cough

    • sore throat • nasal and sinus congestion

    • temporarily reduces fever

  • 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 or severe allergic reactions. Symptoms may include:

    • skin reddening • blisters • rash • hives

    • facial swelling • asthma (wheezing) • shock

    If a skin or general allergic 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

    • in children under 12 years of age

  • Ask a doctor before use if you have

    • liver disease • heart disease • high blood pressure

    • thyroid disease • diabetes

    • cough that occurs with excessive phlegm (mucus)

    • difficulty in urination due to enlargement of the prostate gland

    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

  • WHEN USING

    When using this product do not exceed recommended dosage

  • Stop use and ask a doctor if

    • pain, cough, or nasal congestion 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.

    • nervousness, dizziness, or sleeplessness occurs

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children.

    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

    • do not take more than the recommended dose

    • adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.

    • children under 12 years: do not use

  • Other Information

    • store at room temperature. Avoid excessive heat above 40ºC (104ºF).

  • Inactive ingredients

    D&C yellow no.10, FD&C blue no.1, gelatin, glycerin, mica, polyethylene glycol 400, povidone K 30, purified water, sorbitol sorbitan solution, titanium dioxide

  • Bulk package Label

    bulk label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE 
    acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0189
    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 HYDROBROMIDE10 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    1,4-SORBITAN (UNII: AV0YTZ4E6J)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    MICA (UNII: V8A1AW0880)  
    Product Characteristics
    Colorgreen (Glittering) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35916-0189-11000 in 1 BAG; Type 0: Not a Combination Product04/04/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/04/2025
    Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (675584180)