FDA.reportPublic FDA data

TopCare Health Daytime Cold and Flu Relief Daytime

Manufacturer
TopCare Health
Effective date
2022-11-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:51:57

Label at a glance#

ProductTopCare Health Non Drowsy Daytime Cold and Flu Relief And Nighttime Cold and Flu Relief Day and Night Combo Pack
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure9 sections

Indications and uses

Daytime temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever   Nighttime temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever • runny nose & sneezing

Dosage and administration

Daytime • take only as directed - see Overdose warning • do not exceed 4 doses per 24 hours adults & children 12yrs & over one cup every 4 hrs children under 12yrs do not use • place single–serve cup in compatible brewer • use a minimum of 8 oz of water • when finished, the single serve cups are hot and may drip. Tilt the cup during removal to avoid dripping. • DO NOT REMOVE THE FOIL SEAL as the cup will not work ...

Storage and handling

Daytime • store at room temperature   Nighttime

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts Daytime Cold & Flu Relief

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each single serve cup)Purposes

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan HBr 20 mg

Cough suppressant

Phenylephrine HCl 10 mg

Nasal decongestant

Drug Facts Nighttime Cold & Flu Relief

Active ingredients (in each single serve cup)Purposes

Acetaminophen 650 mg

Pain reliever/Fever reducer

Dextromethorphan HBr 30 mg

Cough suppressant

Doxylamine succinate 12.5 mg

Antihistamine

Uses

INDICATIONS & USAGE SECTION

Daytime

temporarily relieves common cold/flu symptoms:

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

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

Daytime

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4 doses 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 reaction. Symptom may include:

  • Skin reddening
  • Blisters
  • Rash

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

  • Nighttime

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4 doses 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 reaction. Symptom 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

Daytime

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

  • Nighttime

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

Do not use

OTC - DO NOT USE SECTION

  • Daytime
  • Nighttime
  • with any other products 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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • Nighttime

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • Daytime
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • 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
  • Nighttime

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

Daytime

taking the blood thinning drug warfarin.

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

Daytime: When using this product, do not use more than directed.

OTC - WHEN USING SECTION

  • Nighttime
  • 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, & tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Daytime
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough gets worse or lasts more than 5 days(children) or 7 days(adults)
  • 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.

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 care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

Daytime

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

Nighttime

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt 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

  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hours

adults & children 12yrs & over

one cup every 4 hrs

children under 12yrs

do not use

  • place single–serve cup in compatible brewer
  • use a minimum of 8 oz of water
  • when finished, the single serve cups are hot and may drip. Tilt the cup during removal to avoid dripping.
  • DO NOT REMOVE THE FOIL SEAL as the cup will not work properly in any single serve compatible brewer and could result in hot water burns.
  • Flush brewer after use
  • Nighttime

adults & children 12yrs & over

one cup every 6 hrs

children under 12yrs

do not use

  • place single-serve cup in any compatible brewer†
  • use a minimum of 8 oz of water
  • when finished, the single serve cups are hot and may drip.
  • Tilt the cup during removal to avoid dripping.

Other information

STORAGE AND HANDLING SECTION

Daytime

  • store at room temperature
  • Nighttime

Inactive ingredients

INACTIVE INGREDIENT SECTION

Daytime

citric acid, FD&C Red No. 40, flavors, isomalt, silica, sucralose

Nighttime

citric acid, FD&C Yellow No.6, flavors, isomalt, silica, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

Daytime

1-866-467-2748

Nighttime

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DAY & NIGHT COMBINATION PACK

TopCare Health™

NDC 36800-562-08

COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® DAYQUIL® COLD & FLU*

Non-Drowsy

Daytime

Cold & Flu Relief

Single serve

Cups

COMPATIBLE WITH KEURIG® K- CUP Brewers & Keurig 2.0 Brewing System, Realcup® Brewers, Remington Icoffe® Express™ Brewers and other single-serve pod machine and personal cup brewers,

Day Time Cold & Flu

Pain reliever/Fever reducer, ACETAMINOPHEN

Cough suppressant

DEXTROMETHORPHAN Habra

Nasal decongestant

PHENYLEPHRINE HCl

Relieves:

  • Headache, fever, sore throat
  • Minor aches & pains
  • Nasal congestion
  • Cough

Berry Flavor infused with Menthol & Green Tea Flavors

Naturally and Artificially Flavored

Alcohol free

4 DAYTIME CUPS

Compare to the active ingredients in Vicks® NyQuil®Cold & Flu*

Nighttime

Cold & Flu Relief
Single Serve Cups

K-CUP®/REAL CUP® POD COMPATIBLE

ACETAMINOPHEN

Pain reliever/Fever reducer

DEXTROMETHORPHAN HBr

Cough suppressant
DOXYLAMINE SUCCINATE

Antihistamine

Relieves:

  • Headache, fever, sore throat
  • Minor aches and pains
  • Sneezing, runny Nose
  • Cough
  • Honey Lemon Flavor Infused Chamomile & White Tea Flavors

4 NIGHTTIME CUPS

8 TOTAL SINGLE SERVE CUPS

Our single serve cold and flu relief cups are a warm and easy way to feel better fast. Just use our cups as you would any other single serve cup in your single serve machine for a great- tasting, flu-relieving drink anytime .Whether you need a non- drowsy way to get through a long day ahead ,or you are finally tucking yourself into bed at night, take a moment and toast to relief.

*This product is not manufactured or distributed by Procter and Gamble Company, owner of the registered trademark Vicks® DayQuil ®Cold & Flu and Vicks® NyQuil® Cold &Flu.

†COMPATIBLE WITH KEURIG® K- CUP® BREWERS & Keurig 2.0 BREWING SYSTEMS.

THIS PRODUCT IS NOT AFFILIATED WITH KEURIG, INC.

Distributed by: TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO RARA0219

QUESTIONS? 1-888-423-0139

topcare@topco.com

www.topcarebrand.com

QualityGuarantee

This TopCare product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

PATENT PENDING

TAMPER EVIDENT POUCH: THIS PACKAGE IS SAFETY SEALED & CHILD RESISTANT. PRODUCT IS PACKEGED IN INDIVIDUAL SEALED POUCHES. DO NOT USE IF SEALED CUP IS TORN AND BROKEN.

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE .KEEP CARTON FOR REFERENCE, DO NOT DISCARD.

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 4 DOSES IN ANY 24 –HOUR PERIOD.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF DAYTIME PRODUCT UNLESS DIRECTED BY DOCTOR.

TopCare Daytime & NiteTime Acetaminophen
TopCare Daytime & NiteTime Acetaminophen

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2119242{1 (acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG Powder for Oral Solution) } PackGPCK4
2119242{1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG Powder for Oral Solution) } PackPSN4
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSN4
1805288acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG Powder for Oral SolutionPSN4
1659967acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD4
1805288acetaminophen 650 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG Powder for Oral SolutionSCD4
2119242{1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG Powder for Oral Solution) } PackSY4
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral SolutionSY4
1805288acetaminophen 650 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG Granules for Oral SolutionSY4
1659967APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY4
1805288APAP 650 MG / Dextromethorphan Hydrobromide 30 MG / doxylamine succinate 12.5 MG Powder for Oral SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE 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
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-562-082024-01-30C16284748780-11030e365-2d57-111a-e063-dadaa90a10e2TopCare health ™ Day and Night Combination Pack Non-Drowsy Daytime Cold and Flu Relief Single Serve Cups Nighttime Cold and Flu Relief Single Serve Cups

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-562-08TopCare Health Non Drowsy Daytime Cold and Flu Relief And Nighttime Cold and Flu ReliefDay and Night Combo Pack1 in 1 KITKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-562TOPCARE HEALTH NON DROWSY DAYTIME COLD AND FLU RELIEF AND NIGHTTIME COLD AND FLU RELIEF DAY AND NIGHT COMBO PACK (ACETAMINOPHEN ,DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HCL ,ACETAMINOPHEN,DEXTROMETHORPHAN HBR,DOXYLAMINE SUCCINATE) KIT [TOPCARE HEALTH]4Legacy NDC, 1 package rows20221201_90358b3c-63c9-4aef-a241-9a6e588535d5.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
36800-56236800-562-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
ISOMALTS870P55O2WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ISOMALTS870P55O2WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT

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
19826132-4b2e-4c61-87f1-50ccb4d8173f90358b3c-63c9-4aef-a241-9a6e588535d52022-11-30WarningsExact identifier
spl id: 19826132-4b2e-4c61-87f1-50ccb4d8173f
spl set id: 90358b3c-63c9-4aef-a241-9a6e588535d5

Reported adverse events (FAERS/openFDA)#

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