KROGER ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [THE KROGER CO]

KROGER ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [THE KROGER CO]
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NDC 30142-773-08
Set ID 36705f6c-bfac-319a-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager THE KROGER CO
Generic Name
Product Class
Product Number
Application Number PART341
  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    (in each 30 mL (2 TBSP))

    Chlophedianol HCl 25 mg

    Pyrilamine Maleate 50 mg

  • PURPOSE

    Purpose

    Cough suppressant

    Antihistamine

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

    • cough due to minor throat and bronchial irritation
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
  • WARNINGS

    Warnings

    Do not exceed recommended dosage.

  • ASK DOCTOR

    Ask a doctor before use if you have

    • a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland
    • a sodium restricted diet
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

  • WHEN USING

    When using this product

    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
  • STOP USE

    Stop use and ask a doctor if:

    • nervousness, dizziness or sleeplessness occurs
    • symptoms do not improve within 7 days, tends to recur, or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
    • new symptoms occur
  • PREGNANCY OR BREAST FEEDING

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

  • 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 4 doses in any 24-hr 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 6-8 hours
    • Children under 12: do not use
  • STORAGE AND HANDLING

    Other information

    • each 30 mL (2 TBSP) contains: Sodium 13 mg
    • tamper evident: Do not use if foil seal under cap is broken or missing
    • read all product information before using
    • store at 68° to 86°F (20° to 30°C).
    • avoid excessive heat and humidity
  • INACTIVE INGREDIENT

    Inactive ingredients

    Anhydrous citric acid, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

  • QUESTIONS

    Questions or comments?

    1-800-632-6900

  • KROGER ALLERGY RELIEF 8 fl oz (237 mL) Bottle Label

    Kroger Allergy Label1

    Kroger Allergy Label2

  • INGREDIENTS AND APPEARANCE
    KROGER ALLERGY RELIEF 
    chlophedianol hydrochloride, pyrilamine maleate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-773
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE50 mg  in 30 mL
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE25 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-773-08237 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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