Doctor Manzanilla Cough And Cold
FDA Label NDC 62558-003

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 And Cold (NDC 62558-003). 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 drug facts, purpose:, uses:, warnings:, keep out of reach of children., directions:, other information:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 15° - 30°C (59°-86°F). Each dose contains 10 mg sodium.

Inactive Ingredients:

Caramel Color, Oregano Extract, Citric Acid, Glycerin, Propylene Glycol, Sorbitol, Sucralose, Edetate Calcuim Disodium, Sodium Benzoate, Natural Chamomile Flavor, Natural Cherry Flavor, Purified Water.

Adverse Reactions:

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

Doctor Manzanilla Coughcold Carton

Doctor Manzanilla CoughCold Carton Label

Doctor Manzanilla

100%

Manzanilla Natural

Doctor Manzanilla

Syrup Jarabe

Cough & Cold

Tos y Resfriado

Scientifically Formulated

Throat Irritation

Itching Watery eyes

Nasal Congestion

Cough

Bronquial

Irritation

4 FL OZ. (118 ml)

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

Phenylephrine HCl 5mg/5 mL (Nasal Decongestant)

100% Manzanilla Natural

PARA EL GUSTO DE TU TRANQUIL!IDAD

Alivia!

Tos

Congestion Nasal

Irritacion de Garganta

Estornudo

Picazon de ojos llorosos

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
Raymondville, TX 78580

Doctor Manzanilla Coughcold Container

Doctor Manzanilla CoughCold Container Label

Doctor Manzanilla

Syrup Jarabe

COUGH & COLD

Tos y Resfriado

100%

Manzanilla Natural

PARA E GUSTO DE TU TRANZUILIDAD

100% Natural Chamomile

FOR A GREAT SOOTHING TASTE

Distributed by: Midvalley Pharmaceuticals
Raymondville, TX 78580

Container Label

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