FDA.reportPublic FDA data

topcare childrens night time cold and cough

Manufacturer
Topco Associates LLC
Effective date
2019-04-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:25:46

Label at a glance#

Producttopcare childrens night time cold and cough
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

• temporarily relieves: • sneezing • itchy nose or throat • runny nose • itchy, watery eyes due to hay fever • 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. Age Dose children under 4 years of age do not use children 4 to under 6 years of age do not use unless directed by a doctor children 6 to under 12 years of age 10 mL

Storage and handling

• each 5 mL contains: sodium 3 mg • store at 20-25 ° C (68-77 ° F)

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine/cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves:
  • sneezing
  • itchy nose or throat
  • runny nose
  • itchy, watery eyes due to hay fever
  • nasal and sinus congestion
  • cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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 your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts or as occurs with asthma
  • a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not get better within 7 days or occur with fever
  • cough persists for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign 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 right away (1-800-222-1222).

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.

Age

Dose

children under

4 years of age

do not use

children 4 to under

6 years of age

do not use unless

directed by a doctor

children 6 to under

12 years of age

10 mL

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO CHILDREN’S TRIAMINIC® NIGHT TIME COLD & COUGH ACTIVE INGREDIENTS

TRIACTING SYRUP

children’s Night Time Cold & Cough

ANTIHISTAMINE – COUGH SUPPRESSANT

DIPHENHYDRAMINE HCl

NASAL DECONGESTANT – PHENYLEPHRINE HCl

Cough Relief

Runny & Stuffy Nose

Itchy Throat

OUR PHARMACISTS RECOMMEND

Ages 6 to under 12 Years

GRAPE FLAVOR

4 FL OZ (118 mL)

childrens nighttime cold and cough image
childrens nighttime cold and cough image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-859-262024-01-30C16284748780-11030e365-30ce-111a-e063-dadaa90a10e2Topco Associates LLC. Children’s Night Time Cold & Cough Drug Facts

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-85936800-859-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT

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
f0d1f74e-78ad-4a46-8c74-2d2229f8fafa284d37fd-9604-4874-b99b-a119a4ba8c0f2024-07-16WarningsExact identifier
spl set id: 284d37fd-9604-4874-b99b-a119a4ba8c0f

Reported adverse events (FAERS/openFDA)#

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