TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]

  • Home
  • TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]

TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]
PDF | XML
NDC 36800-593-73
Set ID 30bd1f30-aac6-4d97-952e-aca0044c2482
Category HUMAN OTC DRUG LABEL
Packager Topco Associates LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
View All Sections
  • Active ingredients (in each liquid cap)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 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 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 4,000 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

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning: If sore throat is severe, lasts 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.
    •
    if you have ever had an allergic reaction to this product or any of its ingredients
  • Ask a doctor before use if you have

    •
    liver disease
    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    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
    •
    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: 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 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 hrs

    adults & children 12 yrs & over

    2 liquid caps with water every 4 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use
  • Inactive ingredients

    edible dye-free ink*, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

  • Questions or comments?

    1-888-423-0139

  • Package/Label Principal Display Panel

    COMPARE TO VICKS® DAYQUIL® COLD & FLU ACTIVE INGREDIENTS

    MULTI-SYMPTOM RELIEF

    Day Time

    Cold & Flu Relief

    OUR PHARMACISTS RECOMMEND

    PAIN RELIEVER – FEVER REDUCER - ACETAMINOPHEN

    COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr • NASAL DECONGESTANT – PHENYLEPHRINE HCl

    DYE-FREE

    Free of Artifical Dyes and Preservatives

    Alcohol Free

    Antihistamine Free

    Non-Drowsy

    Headache, Fever, Sore Throat, Minor Aches & Pains

    Nasal Congestion • Cough

    16 LIQUID CAPS

    actual size

    7G188-daytime.jpg
  • INGREDIENTS AND APPEARANCE
    TOPCARE DAY TIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-593
    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
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorYELLOW (clear) Scoreno score
    ShapeOVALSize21mm
    FlavorImprint Code 7G1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-593-738 in 1 CARTON07/25/2017
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/25/2017
    Labeler - Topco Associates LLC (006935977)
View All Sections

Related Drugs

Search DailyMed Drugs