Doctor Manzanilla Cough Suppressant And Nasal Decongestant
FDA Label NDC 62558-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mid Valley Pharmaceuticals Llc for the product Doctor Manzanilla Cough Suppressant And Nasal Decongestant (NDC 62558-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients (in each 5ml), purpose, uses:, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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 15° - 30°C (59°-86°F). 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 (Label)

Label (Label)

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