Label: DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT- diphenhydramine hydrochloride, phenylephrine hydrochloride 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 June 29, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each 5mL)

    Diphenhydramine Hydrochloride 12.5mg

    Phenylephrine Hydrochloride 5mg

  • Purpose

    Antihistamine/Cough Suppressant

    Nasal Decongestant

  • Uses:

    Temporarily relieves

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever or other upper respiratory
    • cough associated with a cold
    • the cough reflex that causes coughing
    • nasal congestion
    • Promotes nasal and/or sinus drainage
    • temporarily relieves sinus congestion and pressure.
  • WARNINGS

    Warnings:

    Do not use

    • 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.
    • With any other product containing diphenhydramine,even one used on skin.
    • Do not exceed recommended dosage.
    • If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due an enlarged prostate gland
    • cough that occurs that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm (mucus).

    Ask a doctor or pharmacist

    before use if you are taking sedatives or tranquilizers

    When using this product:

    • do not exceed recommended dosage
    • may cause excitability especially in children
    • may cause "drowsiness"; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    • avoid alcoholic beverages while taking this product
    • use caution when driving a motor vehicle or operating machinery.

    Stop use and ask a doctor if:

    • you get nervous, dizzy, or sleeplessness occurs
    • symptoms do not improve within 7 days, tend to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions:

    Do not take more than 6 doses in 24 hours.

    Adults and children 12 years of age and over 2 teaspoonfuls (10mL) every 4 hours
    Children 6 to under 12 years of age 1 teaspoonfuls (5mL) every 4 hours
    Children under 6 years of age Consult a doctor
  • Other information:

    Store at controlled room temperature 15º - 30ºC (59º-86ºF). Each dose contains 10 mg sodium.

  • Inactive ingredients:

    Citric Acid, Trisodium Citrate, Glycerin, Propylene Glycol, Sorbitol, Sucralose, Propyl Gllate, Edetate Sodium, Sodium Benzoate, Chamomile Flavor, Oregano Extract, Yellow No. 5

  • ADVERSE REACTIONS

    To report serious side effects associated with the use of this product call the Poison Control Center.

  • Package Label

    Doctor Manzanilla

    COUGH SUPPRESSANT & NASAL DECONGESTANT

    I RECCOMEND IT

    LAURA FLORES
    4 FL OZ. (118 ml)

    100%
    Manzanilla Natural

    Relieves!

    Cough

    Nasal

    Decongestant

    Throat

    Irritation

    Sneeze

    Bronchial Irritation

    Itching watery eyes

    Distributed by: Midvalley Pharmaceuticals
    Raymondville, TX 78580

    7 48252 23732 3

    Label

  • INGREDIENTS AND APPEARANCE
    DOCTOR MANZANILLA COUGH SUPPRESSANT AND NASAL DECONGESTANT 
    diphenhydramine hydrochloride, phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62558-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62558-001-181 in 1 CARTON
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/04/2014
    Labeler - Mid Valley Pharmaceuticals LLC (079227119)
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