Label: SHOPRITE NIGHTTIME FLU PLUS SEVERE COLD AND COUGH- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 January 29, 2015

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  • 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-ShopRite

  • SPL UNCLASSIFIED SECTION

    Distributed By: Wakefern Food Corp.
    5000 Riverside Drive
    Keasbey, NJ 08832

  • PRINCIPAL DISPLAY PANEL - 6 Packet Carton

    Compare to: Active Ingredients in Theraflu® Nighttime Severe Cold & Cough

    See New Warnings
    Information & Directions

    ShopRite®

    Nighttime

    FLU & SEVERE
    COLD & COUGH

    ACETAMINOPHEN
    Pain Reliever/Fever Reducer

    DIPHENHYDRAMINE HCl
    Antihistamine/Cough Suppressant

    PHENYLEPHRINE HCl
    Nasal Decongestant

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

    Honey Lemon Infused
    with Chamomile & White Tea Flavor

    6 PACKETS

    PRINCIPAL DISPLAY PANEL - 6 Packet Carton
  • INGREDIENTS AND APPEARANCE
    SHOPRITE NIGHTTIME FLU PLUS SEVERE COLD AND COUGH 
    acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41190-113
    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:41190-113-075 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 - WAKEFERN FOOD CORPORATION (069722418)
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