Label: KROGER ALLERGY RELIEF- chlophedianol hydrochloride, pyrilamine maleate liquid

  • 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 June 30, 2016

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  • 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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