DOCTOR MANZANILLA COUGH AND COLD

Manufacturer
Mid Valley Pharmaceuticals LLC
Effective date
2020-04-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:09:03

Label at a glance#

ProductDOCTOR MANZANILLA COUGH AND COLD
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and 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.

Dosage and administration

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (IN EACH 5ML)

Diphenhydramine Hydrochloride 12.5mg

Phenylephrine Hydrochloride 5mL

PURPOSE:

OTC - PURPOSE SECTION

Antihistamine/Cough Suppressant

Nasal Decongestant

USES:

INDICATIONS & USAGE SECTION

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 SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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:

OTHER SAFETY INFORMATION

Store at controlled room temperature 15º - 30ºC (59º-86ºF). Each dose contains less than 5 mg sodium.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

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:

ADVERSE REACTIONS SECTION

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

Doctor Manzanilla CoughCold Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCartonDoctor 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086720diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN2
1086720diphenhydramine hydrochloride 2.5 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD2
1086720diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
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b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
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42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62558-003-162022-01-28C16284748780-19d75b9d1-1f92-f424-e053-dadaa90a57ceDrug Label
62558-003-162020-04-30C16284748780-19d75b9d1-1f92-f424-e053-dadaa90a57ceDrug Label
62558-003-162020-01-31C16284748780-19d75b9d1-1f92-f424-e053-dadaa90a57ceDrug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62558-003-16DOCTOR MANZANILLA COUGH AND COLD1 in 1 CARTONSYRUP12
62558-003-16DOCTOR MANZANILLA COUGH AND COLD118 mL in 1 BOTTLESYRUP1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62558-003DOCTOR MANZANILLA COUGH AND COLD SYRUP [MID VALLEY PHARMACEUTICALS LLC]2Legacy NDC, 2 package rows20200501_7abace52-4d9c-429b-b9a9-96d06261ef50.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62558-00362558-003-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a485bd93-ce06-59cc-e053-2995a90ab0f07abace52-4d9c-429b-b9a9-96d06261ef502020-04-30Warnings, Adverse reactionsExact identifier
spl id: a485bd93-ce06-59cc-e053-2995a90ab0f0
spl set id: 7abace52-4d9c-429b-b9a9-96d06261ef50

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.