FDA.reportPublic FDA data

Kroger Daytime Nighttime Multisymptom Relief Tablets

Manufacturer
KROGER COMPANY | TIME CAP LABORATORIES, INC. | Marksans Pharma Ltd
Effective date
2026-08-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-08-25 01:02:05

Label at a glance#

ProductDaytime Nighttime
Active ingredientACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE
Label structure11 sections

Dosage and administration

Daytime do not take more than directed (see Overdose warning) do not take more than 12 caplets in any 24-hour period adults and children 12 years of age and over: take 2 caplets every 4 hours children under 12 years of age: do not use Nighttime do not take more than directed (see Overdose warning) do not take more than 8 caplets in any 24-hour period adults and children 12 years of age and over: take 2 caplets eve...

Storage and handling

each caplet contains: sodium 3 mg store at 20-25°C (68-77°F), excursion permitted between 15-30°C (59-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Daytime

Active ingredients (in each caplet)

Acetaminophen 325 mg

Guaifenesin 200 mg

Nighttime

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Triprolidine HCl 1.25 mg

OTC - PURPOSE SECTION

Daytime

Pain reliever/fever reducer

Expectorant

Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

INDICATIONS & USAGE SECTION

Daytime

temporarily relieves these common cold and flu symptoms:

  • minor aches and pains
  • headache
  • sore throat

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily reduces fever

Nighttime

temporarily relieves these common cold and flu symptoms:

  • cough
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever

temporarily reduces fever
controls cough to help you get to sleep

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 12 caplets in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily 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

Daytime

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Nighttime

  • 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

Daytime

  • liver disease
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Nighttime

  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

Daytime

  • if you are taking the blood thinning drug warfarin

Nighttime

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

Daytime

  • do not use more than directed

Nighttime

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

Daytime

  • 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
  • cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
  • new symptoms occur

Nighttime

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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

Daytime

  • do not take more than directed (see Overdose warning)
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years of age and over: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Nighttime

  • do not take more than directed (see Overdose warning)
  • do not take more than 8 caplets in any 24-hour period
  • adults and children 12 years of age and over: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: sodium 3 mg
  • store at 20-25°C (68-77°F), excursion permitted between 15-30°C (59-86°F)

Inactive ingredients Daytime

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red no. 40, FD&C yellow no. 6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

Inactive ingredients Nighttime

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, hypromellose, mica, microcrystalline cellulose, povidone, stearic acid, talc, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-632-6900

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ifc-20sifc-20s

DailyMed Product Concepts#

Product concept, Relation, Version table
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Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41226-67841226-678-02
41226-676
41226-677

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
GUAIFENESIN495W7451VQACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE2S7830E561IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYVINYL ALCOHOL532B59J990IACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MICAV8A1AW0880IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
TRIACETINXHX3C3X673IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-07-08full-release2026-06-01 01:06:40

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 NighttimeACETAMINOPHEN, GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLKROGER COMPANY30d50bbe-0a14-c985-e063-6294a90a47b32026-08-16WarningsExact identifier
ndc (package): 41226-678-02
ndc (product): 41226-678
ndc11 (package): 41226067802
spl id: 5936f713-68fb-6326-e063-6394a90aa04f
spl set id: 30d50bbe-0a14-c985-e063-6294a90a47b3

Reported adverse events (FAERS/openFDA)#

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