Childrens Triacting Nighttime

Manufacturer: QUALITY CHOICE (Chain Drug Marketing Association)
Effective date: 2018-12-26
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 00:39:20

Label at a glance#

ProductChildrens Triacting Nighttime Cold and Cough

Active ingredientPHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

temporarily relieves: sneezing runny 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 give more than 6 doses in 24 hours unless directed by a doctor. mL = milliliter measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product Age Dose children 6 to under 12 years 10 mL every 4 hours children 4 to under 6 years do not use unless directed by a doctor children under 4 years of age do not use

Storage and handling

each 5 mL contains: sodium 3 mg store at 20-25°C (68-77°F) Do not refrigerate protect from light

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-248-449-9300

Websitewww.qualitychoice.com

www.qualitychoice.com

Label contents#

Full prescribing information#

Active ingredients (in each 5 m)

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
- runny 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

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
for the purpose of making your child sleepy

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 exceed recommended dosage
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 give more than 6 doses in 24 hours unless directed by a doctor.
mL = milliliter
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product

Age	Dose
children 6 to under 12 years	10 mL every 4 hours
children 4 to under 6 years	do not use unless directed by a doctor
children under 4 years of age	do not use

Other information

STORAGE AND HANDLING SECTION

each 5 mL contains: sodium 3 mg
store at 20-25°C (68-77°F) Do not refrigerate
protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

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 distributors of Children's Triaminic® Night Time Cold & Cough.

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

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quality Choice Children's Triacting Nighttime Cold & Cough Liquid

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1236048	diphenhydrAMINE/Phenylephrine (Oral Liquid)	diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD Active

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	2
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

Childrens Triacting Nighttime Cold and Cough
Diphenhydramine HCl, Phenylephrine HCl
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
ACESULFAME POTASSIUM
SODIUM BENZOATE
ANHYDROUS CITRIC ACID
EDETATE DISODIUM
FD&C RED NO. 40
PROPYLENE GLYCOL
WATER
TRISODIUM CITRATE DIHYDRATE
FD&C BLUE NO. 1
MALTITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63868-301	63868-301-04

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
Name	UNII	Kind
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
TRISODIUM CITRATE DIHYDRATE	B22547B95K	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
MALTITOL	D65DG142WK	IACT

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 7 · 390 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	SHAMPOO / TOPICAL		186 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SHAMPOO / TOPICAL	0.07 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 61 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	TABLET / ORAL		896 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	CAPSULE / ORAL		35 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / RESPIRATORY (INHALATION)		5 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	GRANULE, FOR SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM / SUBLINGUAL		11 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM, SOLUBLE / ORAL		7 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	GRANULE, FOR SUSPENSION / ORAL		4950 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	POWDER, FOR SUSPENSION / ORAL	45 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	FILM, SOLUBLE / ORAL		44 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	SOLUTION / INTRAMUSCULAR	0.03 %w/v		Exact identifier — unii candidate 47 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / SUBCUTANEOUS		101 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	INJECTION / INTRAVENOUS		3480 mg	Exact identifier — unii candidate 47 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / RECTAL		904 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING / ORAL		46 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, LIQUID FILLED / ORAL	0.08 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION, EXTENDED RELEASE / ORAL		62 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		81 mg	Exact identifier — unii candidate 61 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
6e6aab82-0791-4487-bcd5-a3329df1b389			768d6050-c2fe-4046-9a38-d496d799aa13	2018-12-26	Warnings	Exact identifier spl id: 6e6aab82-0791-4487-bcd5-a3329df1b389 spl set id: 768d6050-c2fe-4046-9a38-d496d799aa13

Reported adverse events (FAERS/openFDA)#

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