Label: COLD, FLU AND SORE THROAT- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

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 November 21, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (in each softgel)

    Acetaminophen 325 mg 

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    • temporarily relieves these common cold and flu symptoms:
      • nasal congestion
      • headache
      • cough
      • minor aches and pains
      • sore throat
    • temporarily reduces fever
    • 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 12 softgels in 24 hours, which is the maximum  daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Allergy alert

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin 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.   

    Ask a doctor before use if you have

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

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

    When using this product, do not use more than directed

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • 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 the recommended dose (overdose) may cause liver damage. 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 directed (see Overdose warning)
    • do not take more than 12 liquid gels in any 24-hour period                                                                                              
    • adults and children 12 years of age and older: take 2 liquid gels every 4 hours
    • children under 12 years of age: do not use
  • Other information

    • store between 15-30°C (59-86°F)
    • avoid excessive heat
  • Inactive ingredients

    FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white edible ink

  • Questions or Comments?

    Call:1-866-322-2439

  • PRINCIPAL DISPLAY PANEL - Carton Label

    CAREONE COLD, FLU & SORE THROAT RELIEF 16 SOFTGELS

    NDC 55316-013-14

    *Compare to the active ingredients in Mucinex® Fast-Max® Cold, Flu & Sore Throat

    Carton Label Front

    Carton Label Back

  • INGREDIENTS AND APPEARANCE
    COLD, FLU AND SORE THROAT 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-013
    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 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    Colororange (clear) Scoreno score
    Shapecapsule (oblong) Size25mm
    FlavorImprint Code PC26
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55316-013-142 in 1 CARTON03/08/2017
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/08/2017
    Labeler - DZA Brands LLC (090322194)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd421293287manufacture(55316-013) , analysis(55316-013)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!