DAY TIME COLD AND FLUENON DROWSY NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]

  • Home
  • DAY TIME COLD AND FLUENON DROWSY NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]

DAY TIME COLD AND FLUENON DROWSY NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]
PDF | XML
NDC 69168-356-29, 69168-356-51
Set ID 3703c8e1-dd8d-4e9e-ac87-8ae6ada3f180
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
View All Sections
  • Active ingredient (in each softgel)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCI 5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant

  • Uses

    temporarily relieves common cold and flu symptoms:    ■ nasal congestion   ■ cough due to minor throat and bronchial irritation   ■ sore throat   ■ headache   ■ minor aches and pains   ■ fever

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses 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, occurs with 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 drugs. 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 an 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 lasts 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.

    In case of accidental overdose, contact a doctor or Poison Control Center immediately (1-800-222-1222). Taking more than the recommended dose (overdose) may cause liver damage. 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 
    ■ do not exceed 4 doses per 24 hours
    ■ Adults and children 12 years and over:     take 2 softgels every 4 hours
    ■ Children 4 to under 12 years: ask a doctor
    ■ Children under 4 years: do not use this

  • Other information

    ■ store at room temperature    ■ do not use if blister is torn or open

  • Inactive Ingredients

    FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution,
    May Contain: titanium dioxide, white edible ink

  • Questions or comments?

    Call toll free 1-888-952-0050

  • Package/Label Principal Display Panel

     Daytime Cold and Flu

    Daytime Cold and Flu

  • INGREDIENTS AND APPEARANCE
    DAY TIME COLD AND FLU NON DROWSY 
    acetaminophen 325 mg, dextromethorphan hbr 10 mg, phenylephrine hci 5 mg capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-356
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-356-298 in 1 BOX; Type 0: Not a Combination Product03/03/2015
    2NDC:69168-356-5120 in 1 BOX; Type 0: Not a Combination Product03/03/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/03/2015
    Labeler - Allegiant Health (079501930)
View All Sections

Related Drugs

Search DailyMed Drugs