Nuvicare Daytime And Nighttime Cold And Flu Softgel Combo Pack

Nuvicare Daytime And Nighttime Cold And Flu Softgel Combo Pack
SPL v1
SPL
SPL Set ID 7fa8e4ad-95cb-4905-90db-d53b3bc87c41
Route
ORAL
Published
Effective Date 2025-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (15 mg)
Inactive Ingredients
Polyethylene Glycol 400 Propylene Glycol Povidone Gelatin Sorbitol Glycerin Fd&c Red No. 40 Fd&c Yellow No. 6 Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-09

Description

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


Medication Information

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

Description

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

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)

Section 34088-5

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 

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.
Section 50567-7

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
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers (NightTime Only)
  • taking the blood thinning drug warfarin
Section 50569-3

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)

Section 51945-4

Section 53414-9

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

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.

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.

Drug Facts

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).
Other Information

■ store between 15-30°C (59-86 °F)

■ avoid excessive heat, cold and humidity

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

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: [email protected]


Structured Label Content

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)

Section 34088-5 (34088-5)

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 

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.
Section 50567-7 (50567-7)

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
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers (NightTime Only)
  • taking the blood thinning drug warfarin
Section 50569-3 (50569-3)

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)

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

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

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.

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.

Drug Facts

Do Not Use: (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).
Other Information (Other information)

■ store between 15-30°C (59-86 °F)

■ avoid excessive heat, cold and humidity

Active Ingredients  (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

Inactive Ingredients (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? (Questions or Comments?)

Call 1 (718) 337-8733 or email: [email protected]


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