Doctor Manzanilla Allergy And Decongestant Relief
FDA Label NDC 62558-002

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 Allergy And Decongestant Relief (NDC 62558-002). 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

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 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:

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

Doctor Manzanilla Allergy Carton Label

Doctor Manzanilla Allergy Carton Label

Doctor Manzanilla

ALLERGY

100%

Natural Chamomile

Doctor Manzanilla

ALLERGY &

DECONGESTANT RELIEF

ALIVIO DE ALERGIA &

DESCONGESTIONANTE

4 FL OZ. (118 ml)

Diphenhydramine HCl

(Antihistamine)

Phenylephrine HCl

(Nasal Decongestant)

100% Manzanilla Natural

PARA EL GUSTO DE TU TRANQUIL!IDAD

Alivia!

Alergias

Congestion Nasal

Irritacion de Garganta

Estornudo

Ojos llorosos

por fiebre de heno

Antistaminico

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

Bar Code

7 62558 00204 1

Doctor Manzanilla Allergy Container Label

Doctor Manzanilla Allergy Container Label

100% Natural Chamomile

Doctor Manzanilla

ALLERGY &

DECONGESTANT RELIEF

ALIVIO DE ALERGIA & DESCONGESTIONANTE

4 FL OZ. (118 mL)

Distributed by: Midvalley Pharmaceuticals
Raymondville, TX 78580

Bar Code

7 62558 00204 1

Container Label

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