Childrens Day Time Cold and Cough Syrup - Best Choice

Manufacturer
Best Choice | Aurohealth LLC
Effective date
2019-11-29
Label type
Human OTC Drug Label
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:56:03

Label at a glance#

ProductChildrens Daytime Cold and Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

temporarily relieves nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold

Dosage and administration

may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor use enclosed dosing cup only. Keep for use with  this product only. Do not use any other dosing device. mL= milliliter tsp = teaspoon full Age Dose children under 4 years of age do not use children 4  to under 6 years of age 5 mL (1 teaspoonful) children 6 to under 12 years of age 10 mL (2 teaspoonfuls)

Storage and handling

each 5 mL oral dose (1 teaspoonful) contains: sodium 1.5 mg store at controlled room temperature 20-25°C (68-77°F) see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL, 1 teaspoonful)

Dextromethorphan HBr, USP 5 mg
Phenylephrine HCl, USP 2.5 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves
    • nasal and sinus congestion
    • cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

WARNINGS SECTION

Do not use

  • in a child under 4 years of age
  • in 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts, or as occurs with asthma

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition.

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

  • may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor
  • use enclosed dosing cup only. Keep for use with  this product only. Do not use any other dosing device.
  • mL= milliliter
  • tsp = teaspoon full
Age
Dose
children under 4 years of age
do not use
children 4  to under 6 years of age
5 mL (1 teaspoonful)
children 6 to under 12 years of age
10 mL (2 teaspoonfuls)

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL oral dose (1 teaspoonful) contains: sodium 1.5 mg
  • store at controlled room temperature 20-25°C (68-77°F)
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C Red # 40, flavors, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate, xanthan gum

Questions or Comments?

OTC - QUESTIONS SECTION

1-855-274-4122


PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

5000 KANSAS AVE

KANSAS CITY, KS 66106

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best Choice®
NDC 63941-973-24

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S
TRIAMINIC® SYRUP DAY TIME COLD & COUGH*

Children's
DAYTIME
COLD & COUGH SYRUP

Each 5 mL (1 tsp) dose of oral solution contains:

5 mg - Dextromethorphan HBr, USP (Cough Suppressant)
2.5 mg - Phenylephrine HCl, USP (Nasal Decongestant)

Relieves:

  • Stuffy Nose
  • Cough

Cherry Flavor

Alcohol Free
4 FL OZ (118 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63941-97363941-973-24

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
23bc7f48-1b3f-49b3-9e9d-44ee8c64e58e5835ab30-2c75-46bb-9a06-5a11a27fd3462020-11-26WarningsExact identifier
spl set id: 5835ab30-2c75-46bb-9a06-5a11a27fd346

Reported adverse events (FAERS/openFDA)#

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