Pediacare Childrens Cough And Congestion Grape Syrup
FDA Label NDC 52412-992

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 Congestion Grape (NDC 52412-992). 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, otc - do not use, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Otc - Purpose

Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr, USP 5 mgCough suppressant
Guaifenesin, USP 100 mgExpectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Otc - Do Not Use

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.

Ask A Doctor Before Use If You Have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - Stop Use

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant 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 dosing cup provided
  • keep dosing cup with product
  • mL=milliliter
    • AGEDOSE
    children under 4 yearsdo not use
    children 4 to under 6 years5 mL every 4 hours
    children 6 to under 12 years10 mL every 4 hours
    adults and children 12 years and over20 mL every 4 hours

Other Information

  • store at 20-25°C (68-77°F)
  • do not refrigerate
  • alcohol-free

Inactive Ingredients

acesulfame potassium, citric acid anhydrous, glycerin, flavor, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin

Principal Display Panel - 118 Ml Bottle Carton

Fast Acting

Pedia
Care®

100% dedicated
to kids™

4 Years & Up

COUGH &
CONGESTION

Relieves:

  • Congestion & Mucus
  • Cough

    • Dextromethorphan HBr, USP (5 mg per 5 mL)
    Guaifenesin, USP (100 mg per 5 mL)

    Non-Drowsy

    Grape Flavor

    4 FL OZ (118 mL)

    Principal Display Panel (118 mL Bottle Carton)

    Principal Display Panel (118 mL Bottle Carton)

* Please review the disclaimer below.