FDA.reportPublic FDA data

Childrens Triacting Nighttime Cold and Cough

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Effective date
2019-11-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:02:24

Label at a glance#

ProductChildrens Triacting Nighttime Cold and Cough
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves: sneezing running nose itchy nose or throat 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

do not take more than 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product tsp = teaspoon, mL = milliliter  age  dose  children 6 to 11 years  2 tsp (10 mL) every 4 hours  children 4 to 5 years do not use unless directed by a doctor  children under 4 years  do not use

Storage and handling

each 5 mL contains: sodium 6 mg contains no aspirin protect from light store at 20º-25°C (68º-77°F). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL, 1 teaspoonful)

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
    • running nose
    • itchy nose or throat
    • 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

  • to make a child sleepy 
  • 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.
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

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

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 use more than directed
  • marked drowsiness may occur
  • 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 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

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • tsp = teaspoon, mL = milliliter
 age dose
 children 6 to 11 years 2 tsp (10 mL) every 4 hours
 children 4 to 5 yearsdo not use unless directed by a doctor
 children under 4 years do not use

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 6 mg
  • contains no aspirin
  • protect from light
  • store at 20º-25°C (68º-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, alcohol, benzoic acid, citric acid, disodium EDTA,Fd&C blue #1,  FD&C red #40, maltitol solution, natural & artificial flavor, propylene glycol, purified water, sodium citrate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredients in Children's Triaminic® Nighttime Cold & Cough

Children's Triacting Nighttime

Cold & Cough

Diphenhydramine HCl

Antihistamine

Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

For Ages 6 to 11

Grape Flavor

FL OZ (mL)

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributors of Children's Triaminic® Night Time Cold & Cough.

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL ON THE BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions:248-449-9300

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 Childrens Triacting Nighttime Cold and CoughChildrens Triacting Nighttime Cold and Cough

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD401
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G91
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
MALTITOLINACTIVE INGREDIENTD65DG142WK1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-36863868-368-04

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
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
BENZOIC ACID8SKN0B0MIMIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MALTITOLD65DG142WKIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 331 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / RECTAL11 mgExact identifier — unii candidate
23 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAMUSCULAR25 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLFILM, SOLUBLE / ORAL7 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE, LIQUID FILLED / ORAL360 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLOIL / TOPICAL2 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / SUBCUTANEOUS101 mgExact identifier — unii candidate
61 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, EFFERVESCENT / ORAL4 mgExact identifier — unii candidate
17 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS35 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCLOTH / TOPICAL4.2 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / SUBCUTANEOUS25 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii candidate
61 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMINJECTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
MALTITOLMALTITOLD65DG142WKFILM / SUBLINGUAL24 mgExact identifier — unii candidate
7 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / BUCCAL30 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSHAMPOO / TOPICAL0.07 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, FILM COATED / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
77 equally ranked IID candidates
MALTITOLMALTITOLD65DG142WKCAPSULE / ORAL155 mgExact identifier — unii candidate
7 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDMOUTHWASH / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / RESPIRATORY (INHALATION)5 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / OPHTHALMIC0.06 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRACARDIAC2 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / NASAL5 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9LOZENGE / ORAL120 mgExact identifier — unii candidate
17 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates

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
75ad1be5-08c0-4726-8392-46198bcabfd8a16514dd-6eee-4c33-b6b1-d8a7eece6aa62019-11-08WarningsExact identifier
spl id: 75ad1be5-08c0-4726-8392-46198bcabfd8
spl set id: a16514dd-6eee-4c33-b6b1-d8a7eece6aa6

Reported adverse events (FAERS/openFDA)#

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