KROGER NITETIME FLU PLUS SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [KROGER COMPANY]

KROGER NITETIME FLU PLUS SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [KROGER COMPANY]
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NDC 30142-113-07
Set ID 656cfa67-301d-4d08-851a-b7d449f1a5ff
Category HUMAN OTC DRUG LABEL
Packager Kroger Company
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each packet)Purposes
    Acetaminophen 650 mgPain reliever/fever reducer
    Diphenhydramine hydrochloride 25 mgAntihistamine/cough suppressant
    Phenylephrine hydrochloride 10 mgNasal decongestant
  • Uses

    • temporarily relieves these symptoms due to a cold:
      • minor aches and pains
      • minor sore throat pain
      • headache
      • nasal and sinus congestion
      • runny nose
      • sneezing
      • itchy nose or throat
      • itchy, watery eyes due to hay fever
      • cough due to minor throat and bronchial irritation
    • temporarily reduces fever
  • Warnings

    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.

    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

    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

    • in a child under 4 years of age
    • if you are allergic to acetaminophen
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • with any other product containing diphenhydramine, even one used on the skin
    • 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
    • glaucoma
    • a sodium-restricted diet
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema, asthma or chronic bronchitis
    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

    Ask a doctor or pharmacist before use if you are taking

    • sedatives or tranquilizers
    • the blood thinning drug warfarin

    When using this product

    • do not exceed recommended dosage
    • avoid alcoholic drinks
    • marked drowsiness may occur
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • symptoms do not get better or worsen
    • pain, cough or nasal congestion gets worse or lasts more than 7 days
    • cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a heath care professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • do not use more than directed
    • take every 4 hours; do not take more than 5 packets in 24 hours unless directed by a doctor
      AgeDose
      children under 4 years of agedo not use
      children 4 to under 12 years of agedo not use unless directed by a doctor
      adults and children 12 years of age and overone packet
    • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
    • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.
  • Other information

    • each packet contains: potassium 4 mg, sodium 27 mg
    • phenylketonurics: contains phenylalanine 34 mg per packet
    • store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.
  • Inactive ingredients

    acesulfame potassium, aspartame, citric acid anhydrous, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch.

  • Questions or Comments?

    Call 1-800-632-6900

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    THE KROGER CO.
    CINCINNATI, OHIO 45202

  • PRINCIPAL DISPLAY PANEL - 6 Packet Carton

    COMPARE TO the active ingredients of THERAFLU®
    NIGHTTIME SEVERE COLD & COUGH
    *See side panel

    SEE NEW WARNINGS
    INFORMATION & DIRECTIONS

    NDC 30142-113-07

    Kroger®

    FROM OUR FAMILY
    TO YOURS

    NiteTime

    Flu + Severe
    Cold & Cough

    Acetaminophen, Pain Reliever/Fever Reducer
    Diphenhydramine HCl, Antihistamine/Cough Suppressant
    Phenylephrine HCl, Nasal Decongestant

    • Nasal Congestion
    • Sore Throat Pain
    • Runny Nose
    • Body Ache
    • Fever
    • Headache
    • Cough
    • Sneezing

    • Our Pharmacists •
    Recommend

    6
    PACKETS

    HONEY
    LEMON

    INFUSED WITH
    CHAMOMILE &
    WHITE TEA FLAVORS

    Principal Display Panel - 6 Packet Carton
  • INGREDIENTS AND APPEARANCE
    KROGER NITETIME FLU PLUS SEVERE COLD AND COUGH 
    acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-113
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen650 mg
    Diphenhydramine hydrochloride (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) Diphenhydramine hydrochloride25 mg
    Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine hydrochloride10 mg
    Inactive Ingredients
    Ingredient NameStrength
    acesulfame potassium (UNII: 23OV73Q5G9)  
    aspartame (UNII: Z0H242BBR1)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    D&C yellow no. 10 (UNII: 35SW5USQ3G)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    anhydrous trisodium citrate (UNII: RS7A450LGA)  
    sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-113-076 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/28/2013
    Labeler - Kroger Company (006999528)