Childrens Cold and Cough

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER | Guardian Drug Company
Effective date
2024-12-16
Label type
Human OTC Drug Label
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:45:32

Label at a glance#

ProductChildrens Cold and Cough
Active ingredientBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

temporarily relieves cough due to minor bronchial irritation as may occur 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): sneezing Itching of the nose or throat runny nose itchy, watery eyes temporarily restores freer breathing through the nose

Dosage and administration

do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not exceed recommended dosage mL = milliliter                      Age                Dose    adults & children  12 years & over   20 mL every 4 hours  children 6 to under  12 years  10 mL every 4 hours  children under 6 years  do not use

Label contents#

Full prescribing information#

ACTIVE INGRADIENTS (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Brompheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 10  mg

Phenylephrine HCl, USP 5 mg

PURPOSES

OTC - PURPOSE SECTION

Antihistamine

Cough Suppressant

Nasal decongestant

USES

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor bronchial irritation as may occur 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):
  • sneezing
  • Itching of the nose or throat
  • runny nose
  • itchy, watery eyes
  • temporarily restores freer breathing through the nose

WARNINGS

WARNINGS SECTION

.

DO NOT USE

OTC - DO NOT USE SECTION

  • to sedate a child or to make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, or  psychiatric, 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

OTC - ASK DOCTOR SECTION

  • heart disease
  • glaucoma
  • diabetes
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to an enlarged prostate gland
  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking any other oral nasal decongestant or stimulant
  • taking sedative or tranquilizers

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • do not take more than directed
  • may cause drowsiness
  • alcohol, sedatives, and tranquillizers may increase drowsiness
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve 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.

IF PREGNANT OR BREAST-FEEDING,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not exceed recommended dosage
  • mL = milliliter

                     Age               Dose  
 adults & children
 12 years & over 
 20 mL
every 4 hours
 children 6 to under
 12 years
 10 mL
every 4 hours
 children under 6 years do not use



OTHER INFORMATION

OTHER SAFETY INFORMATION

  • each 10 mL contains: sodium 10 mg
  • store at 20-25ºC (68-77ºF)
  • measuring cup provided

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C Red #40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

call (609) 860-2600 Mon - Fri 8:00 am to 4:30 pm est

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER

NDC 70000-0631-1

Children's Cold & Cough Liquid

Brompheniramine Maleate

Dextromethorphan Hydrobromide

Phenylephrine Hydrochloride

Antihistamine 

Cough Suppressant

Nasal Decongestant
Grape

Flavor

Relieves:

Stuffy Nose,

Runny Nose,

Sneezing,

Cough

Alcohol-Free

COMPARE TO CHILDREN'S DIMETAPP®

COLD & COUGH

active ingredients*

4 FL OZ (118 mL)

LDR_577_CrtLDR_577_Crt

ldr_577_lblldr_577_lbl

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0631CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE HCL) LIQUID [CARDINAL HEALTH 110, LLC. DBA LEADER]2Unmatched20241219_24c1f90c-7b2e-4e86-a2f6-d23f74e0708b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0631-1ML - Milliliter70000-063148d3bb9a-c5a0-4a08-a1c2-a37b31dd0d2612023-08-08

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-063170000-0631-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
5ec28941-7fd9-4e75-94b0-5f5d76df95d124c1f90c-7b2e-4e86-a2f6-d23f74e0708b2026-03-16WarningsExact identifier
spl set id: 24c1f90c-7b2e-4e86-a2f6-d23f74e0708b

Reported adverse events (FAERS/openFDA)#

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