FDA.reportPublic FDA data

Daytime Nighttime

Manufacturer
TARGET CORPORATION | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2023-11-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:11:38

Label at a glance#

ProductDaytime Nighttime Ultra Concentrated Cold and Flu
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE
Label structure35 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 LiquiCaps per 24 hrs adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Storage and handling

store at no greater than 25°C

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

VICKS® DayQuil™ ULTRA CONCENTRATED COLD & FLU, LiquiCaps™

Drug Facts

DayQuil™ Cold & Flu

Active Ingredient (in each LiquiCap)

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:

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 Liquicaps 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:

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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

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.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. 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 LiquiCaps per 24 hrs

adults & children 12 yrs & over2 LiquiCaps with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

store at no greater than 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Yellow No. 5, FD&C Yellow No. 6, gelatin, glycerin, lecithin, mica, polyethylene glycol, polyvinyl acetate phthalate, povidone, sorbitol sorbitan solution, titanium dioxide, water

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

SPL UNCLASSIFIED SECTION

VICKS® NyQuil™ ULTRA CONCENTRATED COLD & FLU, LiquiCaps™

Drug Facts

NyQuil™ Cold & Flu

Active Ingredient (in each LiquiCap)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation

• sore throat

• headache

• minor aches & pains

• fever

• runny nose & sneezing

Warnings

WARNINGS SECTION

Liver warning:

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 Liquicaps 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:

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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

• glaucoma

• cough that occurs with too much phlegm (mucus)

• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

• trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

• Do not use more than directed

• excitability may occur, especially in children

• marked drowsiness may occur

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

• alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

• pain 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.

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. 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 LiquiCaps per 24 hrs

adults & children 12 yrs & over2 LiquiCaps with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

store at no greater than 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, lecithin, mica, polyethylene glycol, polyvinyl acetate phthalate, povidone, sorbitol sorbitan solution, titanium dioxide, water

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS® DayQuil™ | VICKS® NyQuil™ ULTRA CONCENTRATED COLD & FLU, LiquiCaps™

MAX STRENGTH

2X VALUE PACK†

VICKS® DayQuil™

ULTRA CONCENTRATED

COLD & FLU

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal Congestion, Sinus Pressure

Cough

25% SMALLER*

EASY TO
SWALLOW

Non-Drowsy

48 DAYQUIL LIQUICAPS™

VICKS® NyQuil™

ULTRA CONCENTRATED

COLD & FLU

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Sneezing, Runny Nose

Cough

25% SMALLER*

EASY TO SWALLOW

Nighttime Relief

48 DAYQUIL LIQUICAPS™ 48 NYQUIL LIQUICAPS™ 96 TOTAL LIQUICAPS™

802802

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1648203{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCK1
16482031 daytime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSN1
1426334acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral CapsulePSN1
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN1
1867684acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral CapsulePSN1
1426334acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD1
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD1
1867684acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral CapsuleSCD1
16482031 daytime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSY1
1867684acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral CapsuleSY1
1426334APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSY1
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY1
1867684APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-757-83Daytime NighttimeUltra Concentrated Cold and Flu1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-757DAYTIME NIGHTTIME ULTRA CONCENTRATED COLD AND FLU (DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE) KIT [TARGET CORPORATION]1Current NDC, 1 package rows20240501_093eed84-79b1-7914-e063-6394a90a37af.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-75711673-757-83
11673-714
11673-758

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICAV8A1AW0880IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
GELATIN2G86QN327LIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYVINYL ACETATE PHTHALATE58QVG85GW3IACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ACETAMINOPHEN362O9ITL9DACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
SORBITOL506T60A25RIACT
MICAV8A1AW0880IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
GELATIN2G86QN327LIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYVINYL ACETATE PHTHALATE58QVG85GW3IACT
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ACETAMINOPHEN362O9ITL9DACTIB

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 Nighttime Ultra Concentrated Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION093eed84-79b1-7914-e063-6394a90a37af2023-11-03WarningsExact identifier
ndc (package): 11673-757-83
ndc (product): 11673-757
ndc11 (package): 11673075783
spl id: 093eed38-ea64-92a1-e063-6294a90a12fd
spl set id: 093eed84-79b1-7914-e063-6394a90a37af

Reported adverse events (FAERS/openFDA)#

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