Label: DOCTOR MANZANILLA ALLERGY AND DECONGESTANT RELIEF 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.

View All Sections
  • DRUG FACTS:

    ACTIVE INGREDIENTS (IN EACH 5ML)

    Diphenhydramine Hydrochloride 12.5mg

    Phenylephrine Hydrochloride 5mL

  • PURPOSE:

    Antihistamine

    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 allergies or allergic rhinitis
    • 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. If symptoms do not improve within seven days or are accompanied by fever, 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 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, Sorbitol, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Stevia, Sucralose.

  • ADVERSE REACTIONS:

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

  • Doctor Manzanilla Allergy Carton Label

    CartonDoctor Manzanilla Allergy and Decongestant Carton

    Doctor Manzanilla

    ALLERGY

    100% Natural Chamomile

    Doctor Manzanilla

    ALLERGY &

    DECONGESTANT RELIEF

    4 FL OZ. (118 ml)

    Diphenhydramine HCl

    (Antihistamine)

    Phenylephrine HCl

    (Nasal Decongestant)

    100% Manzanilla Natural

    Congestion Nasal

    Doctor Manzanilla

    100% Natural Chamomile

    FOR A GREAT SOOTHING TASTE

    Relieves!

    Allergy

    Nasal Decongestant

    Itchy Throat

    Sneezing

    Itching watery eyes

    Antihistamine

    Doctor Manzanilla

    Distributed by: Midvalley Pharmaceuticals
    Raymondville, TX 78580

  • INGREDIENTS AND APPEARANCE
    DOCTOR MANZANILLA ALLERGY AND DECONGESTANT RELIEF 
    doctor manzanilla allergy and decongestant relief syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62558-002
    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) PHENYLEPHRINE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    STEVIA LEAF (UNII: 6TC6NN0876)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Colorbrown (Caramel Color) Score    
    ShapeSize
    FlavorCHERRY (Natural) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62558-002-041 in 1 CARTON01/12/2017
    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 finalpart34101/12/2017
    Labeler - Mid Valley Pharmaceuticals LLC (079227119)
    Registrant - Mid Valley Pharmaceuticals LLC (079227119)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!