Nuvicare Daytime Cold And Flu Softgel (acetaminophen 325mg, Dextromethorphan Hbr 10mg, Phenylephrine Hcl 5mg)

Nuvicare Daytime Cold And Flu Softgel (acetaminophen 325mg, Dextromethorphan Hbr 10mg, Phenylephrine Hcl 5mg)
SPL v1
SPL
SPL Set ID bdc35570-c8df-4797-a13e-7f2479ec42b7
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)
Inactive Ingredients
Polyethylene Glycol 400 Propylene Glycol Povidone Water Gelatin Sorbitol Sorbitan Glycerin Fd&c Red No. 40 Fd&c Yellow No. 6

Identifiers & Packaging

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

Description

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


Medication Information

Purpose

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

Dextromethorphan HBr 10mg..................... Cough suppressant

Phenylephrine HCl 5mg ............................. Nasal decongestant

Description

Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg

Uses:

temporarily relieves common cold and flu symptoms:

■ minor aches & pains

■ headache

■ sore throat

■ nasal congestion

■ fever

■ 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 (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.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.
Section 50567-7

When using this product, do not exceed recommeded dosage.

Section 50568-5
Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
Section 50569-3

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)

Section 51945-4

Section 53414-9

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

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.

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

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.
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: [email protected]

Active Ingredients (in Each Softgel)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg


Structured Label Content

Uses:

temporarily relieves common cold and flu symptoms:

■ minor aches & pains

■ headache

■ sore throat

■ nasal congestion

■ fever

■ 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 (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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.
Section 50567-7 (50567-7)

When using this product, do not exceed recommeded dosage.

Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
Section 50569-3 (50569-3)

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)

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 10mg..................... Cough suppressant

Phenylephrine HCl 5mg ............................. Nasal decongestant

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.

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

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.
Other Information (Other information)

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

■ avoid excessive heat, cold and humidity

Inactive Ingredients (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? (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 10mg

Phenylephrine HCl 5mg


Advanced Ingredient Data


Raw Label Data

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