KROGER NITETIME COLD AND FLU (CHOLINE SALICYLATE, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [THE KROGER CO]

KROGER NITETIME COLD AND FLU (CHOLINE SALICYLATE, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [THE KROGER CO]
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NDC 30142-772-08
Set ID 3685e6fe-e001-103b-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager THE KROGER CO
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    (in each 30 mL (2 TBSP))

    Choline Salicylate (NSAID)* 870 mg

    Diphenhydramine HCl 50 mg

    Phenylephrine HCl 10 mg

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose

    Pain reliever / fever reducer

    Antihistamine

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves these common cold and flu symptoms:

    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
    • watery eyes
    • temporarily reduces fever
  • WARNINGS

    Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert: Salicylates (NSAIDs) may cause a severe allergic reaction which may include:

    • hives
    • rash
    • shock
    • skin reddening
    • facial swelling
    • asthma (wheezing)

    Stomach bleeding warning:

    This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    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

    Do not use

    • if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever / fever reducer.
    • with any other drug 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 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.
    • in children under 12 years of age
  • ASK DOCTOR

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes, thyroid disease, or glaucoma
    • you have a cough with excessive phlegm (mucus)
    • you have difficulty in urination due to enlargement of the prostate gland
    • you have breathing problems such as emphysema or chronic bronchitis
    • you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • you have a sodium restricted diet.
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking a precription drug for anti-coagulation (thinning the blood), diabetes, gout, or arthritis
    • taking a diuretic
    • under a doctor's care for any serious condition
    • taking sedatives or tranquilizers
  • WHEN USING

    When using this product

    • do not use more than directed
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
  • STOP USE

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • pain, cough, or nasal congestion 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
    • ringing in the ears or a loss of hearing occurs
    • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
    • nervousness, dizziness, or sleeplessness occurs
    • you experience any of the following signs of stomach bleeding
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use salicylates (NSAIDs) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Do not exceed recommended dosage.
    • Do not take more than 6 doses in any 24-hour period.
    • Use enclosed dose cup
    • Keep dosage cup with product
    • TBSP=tablespoon
    • mL-milliliter
    • Adults and children 12 years and over: 30 mL (2 TBSP) every 4 hours
    • Children under 12: Do not use
  • STORAGE AND HANDLING

    Other information

    • each 30 mL (2 TBSP) contains: Sodium 25 mg
    • tamper evident: Do not use if foil seal under cap is broken or missing.
    • read all product information before using
    • store at room temperature 68°-86°F (20°-30°C)
    • avoid excessive heat and humidity
  • INACTIVE INGREDIENT

    Inactive ingredients

    Edetate disodium, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

  • QUESTIONS

    Questions or comments?

    1-800-632-6900

  • Kroger NiteTime Cold & Flu 8 fl oz (237 mL) Bottle Label

    Kroger NiteTime Label1

    Kroger NiteTime Label2

  • INGREDIENTS AND APPEARANCE
    KROGER NITETIME COLD AND FLU 
    choline salicylate, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-772
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
    CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ) CHOLINE SALICYLATE870 mg  in 30 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-772-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/07/2016
    Labeler - THE KROGER CO (006999528)

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