Childrens Tussin Dm
FDA Label NDC 71027-032

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kingston Pharma Llc for the product Childrens Tussin Dm (NDC 71027-032). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, 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

Otc - Active Ingredient

Active Ingredient: Active Ingredient: Dextromethorphan HBr 5mg, Guaifenesin 100mg (in each 5 mL)

Otc - Purpose

Purpose:
Cough suppressant
Expectorant

Indications & Usage

  • 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 coughs more productive

Warnings

DO NOT USE IF PRINTED SEAL OVER IS TORN OR MISSING

Warnings:

Otc - Do Not Use

Do not use if a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Otc - Ask Doctor

Ask a doctor before use if the child has

  • Cough that occurs with too much phlegm (mucus)
  • Persistent or chronic cough such as occurs with asthma

Otc - When Using

Stop use and ask doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children. In case of overdose, seek professional assistance or contact a Poison control center right away.

Otc - Pregnancy Or Breast Feeding

Dosage & Administration

Directions:

  • This product does not contain directions or complete warnings for adult use.
  • Use only enclosed dosing cup provided.
  • Do not take more than 6 doses in any 24-hour period.
  • Children 6 years to under 12 years: 5 mL – 10 mL taken every 4 hours.
  • Children 4 years to under 6 years: 2.5 mL – 5 mL taken every 4 hours.
  • Children under 4 years: do not use.

Storage And Handling

Other information

  • each teaspoon contains: sodium 4 mg
  • store at 20°-25°C (68°-77°F)

Inactive Ingredient

Inactive ingredients
Anhydrous citric acid, Artificial & Natural flavors, FD&C Blue#1, FD&C red 40, Sucralose, Glycerin, Polyethylen Glycol, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Benzoate

How Supplied

(packs: 4oz) Kingston NDC# 71027-036-04

Manufactured by: Kingston Pharma LLC
5 County Route 42
Massena, NY 13662

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