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

Nuvicare DayTime Cold and Flu Softgel by

Drug Labeling and Warnings

Nuvicare DayTime 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 10mg

Phenylephrine HCl 5mg

Purpose

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

Uses:

temporarily relieves common cold and flu symptoms:

■ minor aches & pains

■ headache

■ sore throat
■ nasal congestion

■ fever

■ cough due to minor throat & bronchial irritation

Warning

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:

• 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.

ASK DOCTOR

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)

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

WHEN USING

When using this product, do not exceed recommeded dosage.

STOP USE

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.

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 (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

■ 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

Other information

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

■ avoid excessive heat, cold and humidity

Inactive ingredients

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?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84324-023
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)
WATER (UNII: 059QF0KO0R)
Gelatin (UNII: 2G86QN327L)
Sorbitol (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
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	21mm
Flavor		Imprint Code	DL01
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84324-023-01	1 in 1 CARTON	06/09/2025
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	06/09/2025

Labeler - NUVICARE LLC (119257565)

Registrant - NUVICARE LLC (119257565)