Nuvicare Nighttime Cold And Flu Softgel (acetaminophen 325mg, Dextromethorphan Hbr 15mg, Doxylamine Succinate 6.25 Mg)

Nuvicare Nighttime Cold And Flu Softgel (acetaminophen 325mg, Dextromethorphan Hbr 15mg, Doxylamine Succinate 6.25 Mg)
SPL v1
SPL
SPL Set ID 2a29f0ed-d86b-4787-84e0-f7a8c5e7581f
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 (15 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Polyethylene Glycol 400 Propylene Glycol Povidone Water Gelatin Sorbitol Sorbitan Glycerin Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

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

Description

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


Medication Information

Purpose

Acetaminophen 325mg.....................Pain reliever/fever reducer

Dextromethorphan HBr 15mg..................... Cough suppressant

Doxylamine succinate 6.25 mg ............................. Antihistamine

Description

Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25 mg

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

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 as well as  for children even if you do not notice any signs or symptoms. (1-800-222-1222)

Section 42229-5

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

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.
Section 50567-7

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
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedative or tranquilizers.
Section 50569-3

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

Section 51945-4

Section 53414-9

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

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.

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

Drug Facts

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 
Other Information

■ store between 15-30°C (59 to 86 °F)

■ avoid excessive heat

Inactive Ingredients

Polyethylene Glycol400, Propylene Glycol, Povidone 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: [email protected]

Active Ingredients (in Each Softgel)

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25 mg


Structured Label Content

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

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 as well as  for children even if you do not notice any signs or symptoms. (1-800-222-1222)

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.
Section 50567-7 (50567-7)

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
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedative or tranquilizers.
Section 50569-3 (50569-3)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Purpose

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 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.

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

Drug Facts

Do Not Use: (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 
Other Information (Other information)

■ store between 15-30°C (59 to 86 °F)

■ avoid excessive heat

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or Comments?)

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

Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25 mg


Advanced Ingredient Data


Raw Label Data

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