FDA.reportPublic FDA data

Daytime Ultra Concentrated Cold and Flu

Manufacturer
TARGET CORPORATION | TIME CAP LABORATORIES INC | MARKSANS PHARMA LTD
Effective date
2024-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:37

Label at a glance#

ProductDaytime Ultra Concentrated Cold and Flu
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Indications and uses

temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever

Dosage and administration

take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Label contents#

Full prescribing information#

Active ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 softgels in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

When using this product, do not use more than directed

OTC - WHEN USING SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed
  • do not exceed 8 softgels per 24 hrs

    adults & children 12 yrs & over

    		2 softgels with water every 4 hrs

    children 4 to under 12 yrs

    		ask a doctor

    children under 4 yrs

    do not use

Other information

OTHER SAFETY INFORMATION

  • store at no greater than 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow no. 6 Al. lake, gelatin, glycerin, mica, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-910-6874

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

777T-dtultra-48s-label777T-dtultra-48s-label777T-Target-Daytimesoftgels-48s-IFC 1777T-Target-Daytimesoftgels-48s-IFC 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN1
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD1
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY1

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
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-843-48Daytime Ultra Concentrated Cold and Flu1 in 1 CARTONCAPSULE, LIQUID FILLED11
11673-843-48Daytime Ultra Concentrated Cold and Flu48 in 1 BOTTLECAPSULE, LIQUID FILLED481

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-843DAYTIME ULTRA CONCENTRATED COLD AND FLU (ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [TARGET CORPORATION]1Current NDC, 2 package rows20240704_1bc90b2f-612c-e977-e063-6294a90a40b4.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-84311673-843-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHELLAC46N107B71OIACT
GLYCERINPDC6A3C0OXIACT
SORBITAN6O92ICV9RUIACT
GELATIN2G86QN327LIACT
MICAV8A1AW0880IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
POVIDONEFZ989GH94EIACT
SORBITOL SOLUTION8KW3E207O2IACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
POLYETHYLENE GLYCOL 400B697894SGQIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT

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
Daytime Ultra Concentrated Cold and FluACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCLTARGET CORPORATION1bc90b2f-612c-e977-e063-6294a90a40b42024-06-26WarningsExact identifier
ndc (package): 11673-843-48
ndc (product): 11673-843
ndc11 (package): 11673084348
spl id: 1bc90b2f-612d-e977-e063-6294a90a40b4
spl set id: 1bc90b2f-612c-e977-e063-6294a90a40b4

Reported adverse events (FAERS/openFDA)#

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