Childrens Metapp Daytime Liquid
FDA Label NDC 53041-577

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guardian Drug Company for the product Childrens Metapp Daytime (NDC 53041-577). 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 active ingredients (in each 5 ml tsp), purposes, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 5 Ml Tsp)

Brompheniramine maleate 1 mg
Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

Uses

  • temporarily relieves cough due to minor bronchial irritation as may occur with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • sneezing
  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes
  • temporarily restores freer breathing through the nose

Warnings

Do not use

  • to sedate a child or to make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric, or emotional conditions, or parkinsons 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.

Ask A Doctor Before Use If You Have

  • heart disease
  • glaucoma
  • diabetes
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking asthma, chronic bronchitis or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking any other oral nasal decongestant or stimulant
  • taking sedatives or tranquilizers

When Using This Product

  • do not take more than directed
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcohol beverages
  • be careful when driving a motor vehicle or operating mahcinery
  • excitability may occur, especially in children

Stop Use And Ask A Doctor If

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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 any 24-hour period
  • do not exceed recommended dosage
    •  AgeDose 
     adults and children 12 years and over 4 tsp (20 mL) every 4 hours
     children 6 to under 12 years 2 tsp (10 mL) every 4 hours
     children under 6 years do not use

Other Information

  • each teaspoon (tsp) contains: sodium 5 mg
  • store at 20-25oC (68-77oF)
  • measuring cup provided

Inactive Ingredients

anhydrous citric acid, artificial flavor, FD&C BLUE #1, FD&C red 40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Pdp

Compare to the active ingredients in Childrens Dimetapp

Childrens Metapp Daytime

Cold & Cough

Brompheniramine Maleate

Antihistamine

Dextromethorphan HBr

Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

Relieves:

  • Nassal Congestion
  • Soothes Cough
  • Calms allergies

    • Alcohol Free

    For ages 6 years and over

    Grape

    4 FL OZ (118 mL)

    Sn (Gdc577)

    Sn (Gdc577)

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