Nuvicare DayTime Cold and Flu Softgel

Manufacturer
NUVICARE LLC
Effective date
2025-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:41

Label at a glance#

ProductNuvicare DayTime Cold and Flu Softgel
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure17 sections

Indications and uses

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

Dosage and administration

■ take only as directed- see OVERDOSE WARNING ■ do not exceed 8 softgels per 24 hrs.   Adults and children age 12 yrs and over take 2 softgels 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 room temperature between 20-25°C (68-77 °F) ■ avoid excessive heat, cold and humidity

Label contents#

Full prescribing information#

Active ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purpose

OTC - PURPOSE SECTION

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

Uses:

INDICATIONS & USAGE SECTION

temporarily relieves common cold and flu symptoms:

■ minor aches & pains

■ headache

■ sore throat
■ nasal congestion

■ fever

■ cough due to minor throat & bronchial irritation

Warning

WARNINGS SECTION

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.

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 daily while using this product.

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

■ liver disease

■ diabetes

■ heart disease

■ thyroid disease

■ high blood pressure

■ trouble urinating due to enlarged prostate gland

■ persistent or chronic cough as occurs with smoking, asthma, or emphysema

■ cough that occurs with too much phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product, do not exceed recommeded dosage.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • pain, cough or nasal congestion get worse or last more than 7 days
  • new symptoms occur
  • nervousness, dizziness or sleeplessness occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • 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.

OVERDOSAGE SECTION

Overdose warning: 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- see OVERDOSE WARNING

■ do not exceed 8 softgels per 24 hrs. 

 Adults and children age 12 yrs and overtake 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

STORAGE AND HANDLING SECTION

■ store at room temperature between 20-25°C (68-77 °F)

■ avoid excessive heat, cold and humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

Polyethylene Glycol400, Propylene Glycol, Povidone K30, purified water, Gelatin, Glycerol, Sorbitol Sorbitan solution, FD & C Red No. 40, FD &C Yellow No. 6.

Questions or Comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PP0143-00 NC(nosymbol)-Daytime Cold+Flu Soft Gels-10ctPP0143-00 NC(nosymbol)-Daytime Cold+Flu Soft Gels-10ct

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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84324-023-01Nuvicare DayTime Cold and Flu Softgel10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED101
84324-023-01Nuvicare DayTime Cold and Flu Softgel1 in 1 CARTONCAPSULE, LIQUID FILLED11

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84324-02384324-023-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nuvicare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDENUVICARE LLCbdc35570-c8df-4797-a13e-7f2479ec42b72025-06-09WarningsExact identifier
ndc (package): 84324-023-01
ndc (product): 84324-023
ndc11 (package): 84324002301
spl id: 6b80519a-1e97-464a-b7ce-baa26ede64db
spl set id: bdc35570-c8df-4797-a13e-7f2479ec42b7

Reported adverse events (FAERS/openFDA)#

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