FDA.reportPublic FDA data

Triacting Daytime Cold Cough

Manufacturer
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Effective date
2023-10-10
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:56:36

Label at a glance#

ProductTriacting Daytime Cold Cough Childrens
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 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

do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL = milliliter shake well before using  age  dose  children 6 to under 12 years of age  10 mL every 4 hours  children 4 to under 6 years of age  5 mL every 4 hours  children under 4 years of age  do not use

Storage and handling

each 5 mL contains : sodium 2 mg store between 20-25°C (68-77°F). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purposes

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

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.

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

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • mL = milliliter
  • shake well before using
 age dose
 children 6 to under 12 years of age 10 mL every 4 hours
 children 4 to under 6 years of age 5 mL every 4 hours
 children under 4 years of age do not use

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 2 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, alcohol, benzoic acid, citric acid, disodium EDTA, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-309-9030

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients of Children's Triaminic® DayTime Cold & Cough*

For Ages 4 to 11 years

Children's

Triacting

Syrup

Cough Suppressant (Dextromethorphan HBr)

Nasal Decongestant (Phenylephrine HCl)

Day Time Cold & Cough

Alcohol 0.14%

Relieves Cough and Stuffy Nose

Cherry Flavor

FL OZ (mL)

Dosing Cup Included

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributors of Children's Triaminic® Day Time Cold & Cough.

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

DISTRIBUTED BY OLD EAST MAIN CO

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOLLAR GENERAL HEALTH Children's Triacting Syrup Cherry Flavor
DOLLAR GENERAL HEALTH Children's Triacting Syrup Cherry Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1535366dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SuspensionPSN8
1535366dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SuspensionSCD8
1535366dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SuspensionSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-378-04Triacting Daytime Cold CoughChildrens1 in 1 BOXSYRUP18
55910-378-04Triacting Daytime Cold CoughChildrens118 mL in 1 BOTTLE, PLASTICSYRUP1188

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-378TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]8Current NDC, Legacy NDC, 2 package rows20231011_8656aa2e-9546-4de4-9ecc-ce99bf903333.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G93
ALCOHOLINACTIVE INGREDIENT3K9958V90M3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL3
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA3
MALTITOLINACTIVE INGREDIENTD65DG142WK3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V33
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR3
WATERINACTIVE INGREDIENT059QF0KO0R3

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
55910-37855910-378-04

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
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ALCOHOL3K9958V90MIACT
BENZOIC ACID8SKN0B0MIMIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C RED NO. 40WZB9127XOAIACT
MALTITOLD65DG142WKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT

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 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SOLUTION / ORAL117 mgExact identifier — unii+route
26 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTITOLMALTITOLD65DG142WKFILM, SOLUBLE / ORAL44 mgExact identifier — unii+route
10 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, FILM COATED / ORAL1.75 mgExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SUSPENSION / ORAL45 mg/5mlExact identifier — unii+route
26 equally ranked IID candidates
MALTITOLMALTITOLD65DG142WKSUSPENSION / ORAL39600 mg/120mlExact identifier — unii+route
10 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, ORALLY DISINTEGRATING / ORAL24 mgExact identifier — unii+route
26 equally ranked IID candidates
MALTITOLMALTITOLD65DG142WKSOLUTION / ORAL9000 mgExact identifier — unii+route
10 equally ranked IID candidates
MALTITOLMALTITOLD65DG142WKTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii+route
10 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, EFFERVESCENT / ORAL4 mgExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TROCHE / ORAL26 mgExact identifier — unii+route
26 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9SUSPENSION / ORAL160 mgExact identifier — unii+route
26 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, FOR SUSPENSION / ORAL80 mgExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, CHEWABLE / ORAL15 mgExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SOLUTION / ORAL117 mgExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, ORALLY DISINTEGRATING / ORAL24 mgExact identifier — unii+route
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTITOLMALTITOLD65DG142WKTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii+route
10 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TROCHE / ORAL26 mgExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9SUSPENSION / ORAL160 mgExact identifier — unii+route
26 equally ranked IID candidates
MALTITOLMALTITOLD65DG142WKCAPSULE / ORAL155 mgExact identifier — unii+route
10 equally ranked IID candidates
MALTITOLMALTITOLD65DG142WKSOLUTION / ORAL9000 mgExact identifier — unii+route
10 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9SOLUTION / ORAL400 mgExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, CHEWABLE / ORAL15 mgExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9FILM, SOLUBLE / ORAL10 mgExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, FOR SUSPENSION / ORAL80 mgExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9FILM, SOLUBLE / ORAL10 mgExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9LOZENGE / ORAL120 mgExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9SOLUTION / ORAL400 mgExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SUSPENSION / ORAL45 mg/5mlExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, EFFERVESCENT / ORAL4 mgExact identifier — unii+route
26 equally ranked IID candidates
MALTITOLMALTITOLD65DG142WKCAPSULE / ORAL155 mgExact identifier — unii+route
10 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSYRUP / ORAL20 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MALTITOLMALTITOLD65DG142WKSUSPENSION / ORAL39600 mg/120mlExact identifier — unii+route
10 equally ranked IID candidates
MALTITOLMALTITOLD65DG142WKFILM, SOLUBLE / ORAL44 mgExact identifier — unii+route
10 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET / ORAL111 mgExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9LOZENGE / ORAL120 mgExact identifier — unii+route
26 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET / ORAL111 mgExact identifier — unii+route
26 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSYRUP / ORAL20 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, FILM COATED / ORAL1.75 mgExact identifier — unii+route
26 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
Triacting Daytime Cold Cough ChildrensDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8656aa2e-9546-4de4-9ecc-ce99bf9033332023-10-10WarningsExact identifier
ndc (package): 55910-378-04
ndc (product): 55910-378
ndc11 (package): 55910037804
spl id: 63718d09-5af9-49c2-b2e2-00d868e059cd
spl set id: 8656aa2e-9546-4de4-9ecc-ce99bf903333

Reported adverse events (FAERS/openFDA)#

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