Label: DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule

  • NDC Code(s): 68016-877-16, 68016-877-24
  • Packager: Chain Drug Consortium, LLC
  • 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 December 11, 2020

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  • Drug Facts

    Active ingredients (in each capsule)

    Acetaminophen USP 325 mg
    Dextromethorphan HBr USP 10 mg
    Phenylephrine HCl USP 5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:

    • nasal congestion
    • cough due to minor throat & bronchial irritation
    • sore throat
    • headache
    • minor aches & pains
    • fever
  • Warnings

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

    • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
    •  thyroid disease
    • diabetes
    • high blood pressure
    •  trouble urinating due to enlarged prostate gland
    •  cough that occurs with too much phlegm (mucus)
    •  persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • 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


    • you get nervous, dizzy or sleepless
    •  symptoms get worse or last more than 5 days (children) or 7 days (adults)
    •  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 (1-800-222-1222). Quick medical attention is critical for adults & 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 yrs & over
    		2 capsules with water every 4 hrs
    children 4 to under 12 yrs
    		ask a doctor
    children under 4 yrs
    		do not use

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

  • Other information

    • store at room temperature
  • Inactive ingredients

    citric acid anhydrous, gelatin, glycerin, Neelicert FD & C Red No. 40, Neelicert FD & C Yellow No. 6, noncrystallizing sorbitol solution, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, titanium dioxide

  • Questions or comments?

    call 1-855-274-4122
     
    Distributed by:
    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, Pa 19087


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 16 capsule Bottle

    NDC 68016-877-16

    Premier Value


    COMPARE TO THE ACTIVE INGREDIENTS
    IN VICKS® DAYQUIL® COLD & FLU
    MULTI-SYMPTOM RELIEF LIQUICAPS®*

    Multi-Symptom Relief

    Daytime
    COLD & FLU RELIEF

    Acetaminophen, Dextromethorphan HBr and

    Phenylephrine HCl Capsules

    325 mg/10 mg/5 mg 


    • Aches, Fever & Sore Throat
    • Nasal Congestion
    • Cough 

    16 Capsules

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 16 capsule Bottle

  • INGREDIENTS AND APPEARANCE
    DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-877
    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
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGE (orange to reddish orange) Scoreno score
    ShapeOVALSize20mm
    FlavorImprint Code Q01
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-877-168 in 1 CARTON07/12/2019
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:68016-877-2412 in 1 CARTON07/12/2019
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/12/2019
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777MANUFACTURE(68016-877)
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