MedPath

Nuvicare NightTime Cold and Flu Softgel

Nuvicare NightTime Cold and Flu Softgel (Acetaminophen 325mg, Dextromethorphan HBr 15mg, Doxylamine succinate 6.25 mg)

Approved
Approval ID

37a88914-6234-4191-86f5-103c396c52af

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

NUVICARE LLC

DUNS: 119257565

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, Doxylamine succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84324-019
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, Doxylamine succinate
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (11)

ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 15 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
DOXYLAMINE SUCCINATEActive
Quantity: 6.25 mg in 1 1
Code: V9BI9B5YI2
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
GelatinInactive
Code: 2G86QN327L
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/20/2025

PP0130-01 NC(nosymbol)-Nighttime Cold+Flu Soft Gels-10ct

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/20/2025

Uses:

temporarily relieves these common cold/flu symptoms:
■ minor aches & pains

■ headache

■ sore throat

■ fever

■ Runny nose and sneezing

■ cough due to minor throat & bronchial irritation

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/20/2025

Distributed by: Nuvicare LLC, Brooklyn, NY 11211, USA

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/20/2025

Purpose

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/20/2025

Active ingredients (in each softgel)

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25 mg

WARNINGS SECTION

LOINC: 34071-1Updated: 5/20/2025

Warning

**Liver warning:**This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 8 softgels in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks everyday 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.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/20/2025

Do not use:

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

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/20/2025

Ask a doctor before use if you have

■ liver disease

■ glaucoma

■ cough that occurs with too much phlegm (mucus)

■ a breathing problem or chronic cough that last or as occurs with smoking, asthma, chronic bronchitis, or emphysema

■ trouble urinating due to enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 5/20/2025

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedative or tranquilizers.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/20/2025

When using this product

  • do not exceed recommeded dosage.
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedative and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/20/2025

Stop use and ask a doctor if

  • pain or cough get worse or lasts more than 7 days
  • new symptoms 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

LOINC: 53414-9Updated: 5/20/2025

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/20/2025

Keep out of reach of children.

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 5/20/2025

Overdose warning: 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. (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/20/2025

Directions

■ take only as directed- see** OVERDOSE WARNING**

■ do not exceed 8 softgels per 24 hrs.

■ take softgels with water

Adults and children age 12 yrs and over

2 softgels every 6 hrs.

Children 4 to under 12 yrs

ask a doctor

Children under 4 yrs

do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/20/2025

Other information

■ store between 15-30°C (59 to 86 °F)

■ avoid excessive heat

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/20/2025

Inactive ingredients

Polyethylene Glycol400, Propylene Glycol, Povidone (PVP K-30),Purified water, Gelatin, Glycerin, Sorbitol Sorbitan solution, FD & C Blue No. 1, D &C Yellow No.10

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/20/2025

Questions or Comments?

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

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Nuvicare NightTime Cold and Flu Softgel - FDA Drug Approval Details