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

Nuvicare NightTime Cold and Flu Softgel by

Drug Labeling and Warnings

Nuvicare NightTime Cold and Flu Softgel 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 (in each softgel)

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25 mg

Purpose

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

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

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.

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 

ASK DOCTOR

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

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

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

WHEN USING

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

STOP USE

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health 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 as well as  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

• 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

Other information

■ store between 15-30°C (59 to 86 °F)

■ avoid excessive heat

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

Questions or Comments?

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	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	NDC: 84324-019-01	1 in 1 CARTON	05/20/2025
1		10 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	05/20/2025

Labeler - NUVICARE LLC (119257565)