FDA.reportPublic FDA data

Childrens Cough and Cold

Manufacturer
KINGSTON PHARMA LLC
Effective date
2019-01-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:28

Label at a glance#

ProductChildrens Cough and Cold
Active ingredientBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections

Storage and handling

Store between 20°C to 25°C (68° to 77° F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Brompheniramine maleate 1 mg, Dextromethorphan HBr 5mg, Phenylephrine HCl 2.5 mg (in each 5 mL)

OTC - PURPOSE SECTION

Purpose: Children's Cough & Cold

INDICATIONS & USAGE SECTION

Cough & Cold

WARNINGS SECTION

Warnings:

OTC - DO NOT USE SECTION

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.
  • To make a child sleep.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • Glaucoma
  • Thyroid disease
  • High blood pressure
  • Heart disease
  • Diabetes
  • Trouble urinating due to an enlarged prostate gland
  • Persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • Cough that occurs with too much phlegm (mucus)
  • A breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

  • Taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • Do not exceed recommended dosage
  • Excitability may occur especially in children
  • Marked drowsiness may occur
  • Avoid alcoholic drinks
  • Alcohol, sedatives and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery

Stop use and ask doctor if

  • Nervousness, dizziness or sleeplessness occur
  • Symptoms do not get better within 7 days or are accompanied by fever
  • Cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts

A persistent cough may be a sign of a serious condition

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Use enclosed dosing cup.
  • Do not take more than 6 doses in any 24-hour period.
  • Adults and children 12 years and over: take 4 teaspoons or 20 mL every 4-6 hours.
  • Children 6 to under 12 years: take 2 teaspoons or 10 mL every 4-6 hours. ask a doctor
  • Children 4 to under 6 years: do not use unless directed by a doctor
  • Children under 4 years: do not use

STORAGE AND HANDLING SECTION

Store between 20°C to 25°C (68° to 77° F)

INACTIVE INGREDIENT SECTION

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

HOW SUPPLIED SECTION

(packs: 4oz) Kingston NDC# 71027-047-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090463brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN2
1090463brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD2
1090463brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY2
1090463brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71027-047-042020-09-27C16284748780-1ab0e2407-2c43-f274-e053-dbdaa90a6471Children's Cough & Cold Liquid
71027-047-042020-09-25C16284748780-1ab0e2407-2c43-f274-e053-dbdaa90a6471Children's Cough & Cold Liquid
71027-047-042020-07-22C16284748780-1ab0e2407-2c43-f274-e053-dbdaa90a6471Children's Cough & Cold Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71027-047-04Childrens Cough and Cold1 in 1 CARTONLIQUID12
71027-047-04Childrens Cough and Cold118 mL in 1 BOTTLELIQUID1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71027-047CHILDRENS COUGH AND COLD LIQUID [KINGSTON PHARMA LLC]2Legacy NDC, 2 package rows20190206_df3e9800-72c8-4f3a-a25c-89971684ed99.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71027-04771027-047-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BROMPHENIRAMINE MALEATEIXA7C9ZN03ACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

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
42c1ef4e-8dfc-498f-a2ab-f724eb0f6c4adf3e9800-72c8-4f3a-a25c-89971684ed992019-01-30WarningsExact identifier
spl id: 42c1ef4e-8dfc-498f-a2ab-f724eb0f6c4a
spl set id: df3e9800-72c8-4f3a-a25c-89971684ed99

Reported adverse events (FAERS/openFDA)#

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