Label: DOCTOR MANZANILLA COUGH AND COLD syrup

  • 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 April 30, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

    ACTIVE INGREDIENTS (IN EACH 5ML)

    Diphenhydramine Hydrochloride 12.5mg

    Phenylephrine Hydrochloride 5mL

  • 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 - Do not exceed recommended dosage.

    • If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.
    • 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.

    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 marked 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 less than 5 mg sodium.

  • INACTIVE INGREDIENTS:

    Caramel Color, Citric Acid, Glycerin, Natural Chamomile, Natural Cherry Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution, Stevia, Sucralose.

  • ADVERSE REACTIONS:

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

  • Doctor Manzanilla CoughCold Carton

    CartonDoctor Manzanilla CoughCold Carton Carton

    Doctor Manzanilla

    100% Natural chamomile

    Doctor Manzanilla Syrup

    Cough & Cold

    Scientifically Formulated

    Throat Irritation

    Itching Watery eyes

    Nasal Congestion

    Cough

    Irritation

    4 FL OZ. (118 mL)

    Diphenhydramine HCl 12.5mg/5 mL (Cough Suppressant Antihistamine)

    Phenylephrine HCl 5mg/5 mL (Nasal Decongestant)

    Doctor Manzanilla

    100% Natural Chamomile

    FOR A GREAT SOOTHING TASTE

    Relieves!

    Cough

    Nasal Decongestant

    Throat Irritation

    Sneezing

    Itching watery eyes

    Doctor Manzanilla

    Distributed by: Midvalley Pharmaceuticals, LLC

    Raymondville, TX 78580

  • INGREDIENTS AND APPEARANCE
    DOCTOR MANZANILLA COUGH AND COLD 
    doctor manzanilla cough and cold syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62558-003
    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
    STEVIA LEAF (UNII: 6TC6NN0876)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Product Characteristics
    Colorbrown (Caramel Color) Score    
    ShapeSize
    FlavorCHERRY (Natural) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62558-003-161 in 1 CARTON01/09/2017
    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 finalpart34101/09/2017
    Labeler - Mid Valley Pharmaceuticals LLC (079227119)
    Registrant - Mid Valley Pharmaceuticals LLC (079227119)