Label: ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL capsule, liquid filled

  • NDC Code(s): 55629-015-01, 55629-015-02
  • Packager: ONE2ZEE LIMITED LIABILITY COMPANY
  • 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 28, 2021

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

  • Active ingredients (in each capsule)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine Hydrochloride 5 mg

  • Purpose

    Pain reliever/ fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    • temporarily relieves common cold/flu symptoms:

          ο   nasal congestion
          ο   sinus congestion & pressure
          ο   cough due to minor throat & bronchial irritation
          ο   minor aches & pains
          ο   headache
          ο   fever
          ο   sore throat

    • reduces swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
  • Warnings:

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    more than 4 softgels 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

    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.

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    When using this product do not use more than directed

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • pain, nasal congestion, 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 as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • take only as directed - see Overdose warning
    • do not exceed 4 doses per 24 hours

    adults & children 12 years of age and over2 softgels with water every 4 hours
    Children under 12 years of age ask a doctor

    When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

  • Inactive ingredients

    polyethylene glycol 400, propylene glycol, povidone k30, fd&c yellow no. 6, titanium dioxide, gelatin, glycerin, sorbitol, water

  • Other Information:

    • store at room temperature 59°-86°F (15°-30°C)
  • PRINCIPAL DISPLAY PANEL - Shipping Label

    Acetaminophen, Dextromethorphan HBr, Guifenesin, Phenylephrine HCL capsules

    Each Softgel Contains:
    (Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg, Guifenesin 200mg, Phenylephrine Hydrochloride USP 5mg)

    LOT NO:
    DRUM NO:
    MFG DATE:
    QUANTITY:
    NDC NO: 55629-015-
    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.

    Shipper Label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL 
    acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-015
    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
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE K30 (UNII: U725QWY32X)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColororangeScoreno score
    ShapecapsuleSize20mm
    FlavorImprint Code IS4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55629-015-0148 in 1 CARTON03/01/2021
    1NDC:55629-015-02300 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2021
    Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
    Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medgel Private Limited677385498manufacture(55629-015) , analysis(55629-015)