FDA.reportPublic FDA data

Childrens Tussin DM

Manufacturer
KINGSTON PHARMA LLC
Effective date
2017-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:16

Label at a glance#

ProductChildrens Tussin DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose:
Cough suppressant
Expectorant

INDICATIONS & USAGE SECTION

  • 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 SECTION

DO NOT USE IF PRINTED SEAL OVER IS TORN OR MISSING

Warnings:

OTC - DO NOT USE SECTION

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 SECTION

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 SECTION

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 SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Other information

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

INACTIVE INGREDIENT SECTION

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 SECTION

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN1
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY1
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71027-032-042020-01-31C16284748780-19d75b9cf-d26e-f424-e053-dadaa90a57ceChildren’s Tussin DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71027-032-04Childrens Tussin DM118 mL in 1 BOTTLELIQUID1181
71027-032-04Childrens Tussin DM1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71027-032CHILDRENS TUSSIN DM LIQUID [KINGSTON PHARMA LLC]1Legacy NDC, 2 package rows20170319_79bd8e8f-7f05-4de4-8bbb-4b379df78957.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71027-03271027-032-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
SUCRALOSE96K6UQ3ZD4IACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM BENZOATEOJ245FE5EUIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
79bd8e8f-7f05-4de4-8bbb-4b379df7895779bd8e8f-7f05-4de4-8bbb-4b379df789572017-03-01WarningsExact identifier
spl id: 79bd8e8f-7f05-4de4-8bbb-4b379df78957
spl set id: 79bd8e8f-7f05-4de4-8bbb-4b379df78957

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.