Nuvicare DayTime and NightTime Cold and Flu

Manufacturer
NUVICARE LLC
Effective date
2025-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:47

Label at a glance#

ProductNuvicare DayTime and NightTime Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure17 sections

Indications and uses

temporarily relieves common cold/flu symptoms: ■ nasal congestion (DayTime Only) ■ cough due to minor throat & bronchial irritation ■ sore throat ■ headache ■ minor aches & pains ■ fever ■ Runny nose and sneezing (NightTime only)

Dosage and administration

■ take only as directed- see OVERDOSE WARNING ■ do not exceed 8 softgels per 24 hrs.  ■ Take softgels with water DayTime NightTime  Adults and children age 12 yrs and over 2 softgels every 4 hrs.  2 softgels every 6 hrs.   Children 4 to under 12 yrs   ask a doctor  ask a doctor  Children under 4 yrs  do not use do not use Read each label carefully before taking Daytime and Nighttime products.

Storage and handling

■ store between 15-30°C (59-86 °F) ■ avoid excessive heat, cold and humidity

Label contents#

Full prescribing information#

Active ingredients 

OTC - ACTIVE INGREDIENT SECTION

Active ingredients in DayTime (in each softgel)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Active ingredients in NightTime (in each softgel)

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine Succinate 6.25 mg

Purpose

OTC - PURPOSE SECTION

DayTime

Acetaminophen 325mg.....................Pain reliever/fever reducer
Dextromethorphan HBr 10mg..................... Cough suppressant
Phenylephrine HCl 5mg ............................. Nasal decongestant

NightTime 

Acetaminophen 325mg.....................Pain reliever/fever reducer
Dextromethorphan HBr 15mg..................... Cough suppressant
Doxylamine succinate 6.25 mg ............................. Antihistamine

Uses:

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

■ nasal congestion (DayTime Only)

■ cough due to minor throat & bronchial irritation

■ sore throat

■ headache

■ minor aches & pains

■ fever

■ Runny nose and sneezing (NightTime only)

Warning

WARNINGS SECTION

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

■ more than 4 doses in 24 hrs, 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: acetamenophen may cause severe skin recations. Symptoms may include:

■ skin reddening ■ blisters ■ rash. if a skin reactions 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.
  • to make a child sleep (NightTime Only).

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

■ liver disease

■ Glaucoma (NightTime Only)

■ cough that occurs with too much phlegm (mucus)

■ trouble urinating due to enlarged prostate gland

■ a breathing problem, persistent or chronic cough as occurs with smoking, asthma, or emphysema and (NightTime Only) chronic Bronchitis

■ heart disease

■ diabetes (DayTime Only)

■ thyroid disease (DayTime Only)

■ high blood pressure (DayTime Only)

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers (NightTime Only)
  • taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product-do not use more than directed.In addition when using NightTime: 

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machiner
  • alcohol, sedative and tranquilizers may increase drowsiness

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless (DayTime Only)
  • pain, cough or nasal congestion (DayTime only) may get worse or last 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.

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ take only as directed- see OVERDOSE WARNING

■ do not exceed 8 softgels per 24 hrs. 

■ Take softgels with water

DayTime

NightTime

 Adults and children age 12 yrs and over

2 softgels every 4 hrs. 

2 softgels every 6 hrs. 

 Children 4 to under 12 yrs 

 ask a doctor

 ask a doctor

 Children under 4 yrs

 do not use

do not use

Read each label carefully before taking Daytime and Nighttime products.

Other information

STORAGE AND HANDLING SECTION

■ store between 15-30°C (59-86 °F)

■ avoid excessive heat, cold and humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

(Daytime) FD&C Red No. 40, FD&C Yellow No. 6, Gelatin, Glycerin, Polyethylene glycol-400, Povidone (PVPK-30), Propylene glycol,
Purified water, Sorbitol sorbitan solution 

(Nighttime) D&C Yellow No. 10, FD&C Blue No. 1, Gelatin, Glycerin, Polyethylene glycol-400, Povidone (PVPK-30), Propylene glycol, Purified water, Sorbitol sorbitan solution

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1 (718) 337-8733 or email: support@nuvicare.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PP0131-01 NC(nosymbol)-Daytime+Nighttime Cold+Flu Soft Gels-10ct_page-0001 (1)PP0131-01 NC(nosymbol)-Daytime+Nighttime Cold+Flu Soft Gels-10ct_page-0001 (1)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2634564{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } PackGPCK1
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSN1
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN1
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN1
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD1
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD1
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSY1
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY1
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84324-020-01Nuvicare DayTime and NightTime Cold and Flu1 in 1 CARTONKIT11

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84324-02084324-020-01
84324-018
84324-019

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nuvicare DayTime and NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATENUVICARE LLC7fa8e4ad-95cb-4905-90db-d53b3bc87c412025-06-09WarningsExact identifier
ndc (package): 84324-020-01
ndc (product): 84324-020
ndc11 (package): 84324002001
spl id: bc8821d1-bb66-446c-9a78-cd5ae2073532
spl set id: 7fa8e4ad-95cb-4905-90db-d53b3bc87c41
Nuvicare NightTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATENUVICARE LLC37a88914-6234-4191-86f5-103c396c52af2025-05-20WarningsExact identifier
ndc (product): 84324-019
Nuvicare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDENUVICARE LLC1ea15426-4f3d-4a97-a590-6bd73bc6cbcd2025-05-19WarningsExact identifier
ndc (product): 84324-018

Reported adverse events (FAERS/openFDA)#

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