NUVICARE DAYTIME AND NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate kit

Nuvicare DayTime and NightTime Cold and Flu by

Drug Labeling and Warnings

Nuvicare DayTime and NightTime Cold and Flu by is a Otc medication manufactured, distributed, or labeled by NUVICARE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients 

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

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:

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

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:

• 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).

ASK DOCTOR

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)

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

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

WHEN USING

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

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

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

■ 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

■ store between 15-30°C (59-86 °F)

■ avoid excessive heat, cold and humidity

Inactive ingredients

(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?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NUVICARE DAYTIME AND NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84324-020

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84324-020-01	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	06/09/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	6
Part 2	1 BLISTER PACK	6

Part 1 of 2

NUVICARE DAYTIME COLD AND FLU SOFTGEL 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

Product Information
Item Code (Source)	NDC: 84324-018
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
Gelatin (UNII: 2G86QN327L)
Sorbitol (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	red	Score	no score
Shape	capsule (Oblong)	Size	18mm
Flavor		Imprint Code	SD14
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/09/2025

Part 2 of 2

NUVICARE NIGHTTIME COLD AND FLU SOFTGEL 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

Product Information
Item Code (Source)	NDC: 84324-019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
Gelatin (UNII: 2G86QN327L)
Sorbitol (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	green	Score	no score
Shape	capsule (Oblong)	Size	19mm
Flavor		Imprint Code	SD15
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/09/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/09/2025

Labeler - NUVICARE LLC (119257565)

Registrant - NUVICARE LLC (119257565)