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

  • NDC Code(s): 35916-0186-1
  • Packager: Softgel Healthcare Pvt Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 3, 2025

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

  • Active ingredients (in each Capsule)

    Acetaminophen USP 325 mg

    Dextromethorphan Hydrobromide USP 10 mg

    Doxylamine Succinate USP 6.25 mg

    Phenylephrine Hydrochloride USP 5 mg

  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Uses

    temporarily relieves these symptoms due to cold/flu:

    • minor aches and pains
    • headache
    • nasal and sinus congestion
    • cough
    • sore throat
    • runny nose
    • sneezing
    • 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 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 to sedate children.

  • 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
    • glaucoma
    • cough with excessive phlegm (mucus)
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlaragement of the prostate gland
    • persistent or chronic cough such as occurs with smoking,asthma, or emphysema
  • Ask a doctor or pharmacist before use if you are

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

    • do not exceed recommended dosage
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children
  • 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

    Keep out of reach of children. In case of overdose,get medical help or contact a Poison control center right away. Quick medical 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 4 capsules in 12 hours or as

    directed by a doctor.

    • children under 12 years: do not use
  • Other information

    Store at 15ºC- 25ºC (59º-77ºF)

  • Inactive ingredients

    candurin silver sheen, candurin silver sparkle, D&C yellow no.10, FD&C blue no.1, gelatin, glycerin, polyethylene glycol 400, povidone K 30, purified water, sorbitol sorbitan solution

  • Bulk Label

    bulk label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0186
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICA (UNII: V8A1AW0880)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorgreen (Glittering Opaque) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35916-0186-12 in 1 BOX06/11/2025
    13000 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/11/2025
    Labeler - Softgel Healthcare Pvt Ltd (675584180)