Pediacare Childrens Cough And Cold Grape Syrup
FDA Label NDC 52412-920

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Randob Labs,ltd. Dba Crossingwell Consumer Health for the product Pediacare Childrens Cough And Cold Grape (NDC 52412-920). 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, otc - purpose, uses, do not use, 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.

Other

Drug Facts

Distributed by
CrossingWell Consumer Health
PO Box 440
Cornwall, NY 12518

Otc - Purpose

Active ingredients (in each 10 ml)Purposes
Brompheniramine maleate, USP 2 mgAntihistamine
Dextromethorphan HBr, USP 10 mgCough Suppressant
Phenylephrine HCl, USP 5 mgNasal decongestant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation occurring 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):
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
    • temporarily restores freer breathing through the nose

Do Not Use

  • to sedate a child or to make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certaindrugs 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.

Ask A Doctor Before Use If You Have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a 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 use more than directed
  • may cause marked drowsiness
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop Use And Ask A Doctor If

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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
  • measure only with dosage cup provided
  • keep dosing cup with product
  • mL = milliliter
  • agedose
    adults and children 12 years and over20 mL every 4 hours
    children 6 to under 12 years10 mL every 4 hours
    children under 6 yearsdo not use

Other Information

  • store at 20-25°C (68-77°F)

Inactive Ingredients

citric acid anhydrous, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Principal Display Panel - 118 Ml Bottle Carton

Fast Acting

Pedia
Care®

100% dedicated
to kids™

6 Years & Up

COUGH & COLD

Relieves:

  • Stuffy, Runny Nose
  • Itchy, Watery Eyes
  • Sneezing
  • Cough
  • Brompheniramine maleate - Antihistamine
    (2 mg per 10 mL)

    Phenylephrine HCl - Nasal decongestant
    (5 mg per 10 mL)

    Dextromethorphan HBr - Cough suppressant
    (10 mg per 10 mL)

    Alcohol Free

    Grape Flavor

    4 FL OZ (118 mL)

    Principal Display Panel (118 mL Bottle Carton)

    Principal Display Panel (118 mL Bottle Carton)

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