Maximum Strength Nighttime Severe Cold And Flu

Maximum Strength Nighttime Severe Cold And Flu
SPL v11
SPL
SPL Set ID c3d0b70f-d213-4e38-88ab-1c89d93a391d
Route
ORAL
Published
Effective Date 2025-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg) Phenylephrine (5 mg)
Inactive Ingredients
Fd&c Blue No. 1 D&c Yellow No. 10 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Sorbitol Sorbitan Titanium Dioxide Propylene Glycol

Identifiers & Packaging

Pill Appearance
Imprint: 116;A07 Shape: oval Color: green Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-19

Description

Acetaminophen 325mg Dextromethorphan HBr 10mg Doxylamine succinate 6.25mg Phenylephrine HCl 5mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer



Cough suppressant



Antihistamine



Nasal decongestant

Description

Acetaminophen 325mg Dextromethorphan HBr 10mg Doxylamine succinate 6.25mg Phenylephrine HCl 5mg

Uses

• temporarily relieves common cold/flu symptoms



• nasal congestion

  • sinus congestion & pressure



• cough due to minor throat & bronchial irritation



• cough to help you sleep



• minor aches & pains



• headache



• fever

  • sore throat



• runny nose & sneezing



• reduces swelling of nasal passages



• temporarily restores freer breathing through the nose



• promotes nasal and/or sinus drainage

Section 50565-1

Keep out of reach of children. 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.

Section 50566-9

Stop use and ask a doctor if



• you get nervous, dizzy or sleepless



• pain, nasal congestion, or cough gets worse or lasts 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

• excitability may occur, especially in children

• marked drowsiness may occur n avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

• alcohol, sedatives, and tranquilizers may increase drowsiness

Section 50568-5

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if you have

• liver disease

• heart disease

• high blood pressure

• thyroid disease

• diabetes

• glaucoma

• cough that occurs with too much phlegm (mucus)

• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

• trouble urinating due to enlarged prostate gland

Section 50570-1

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.

Section 53414-9

If pregnant or breast-feeding,

ask a health professional before use.

Warnings

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 every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:



• skin reddening



• blisters



• rash



If a skin reaction 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
  • do not exceed 8 softgels per 24 hour
adults & children 12 years & over 2 softgels with water every 4 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

Drug Facts

Other Information

• do not exceed 25°C (77°F)

Inactive Ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, sodium hydroxide*, titanium dioxide



* may contain this ingredient

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Compare to Vicks® NyQuil® Severe Cold & Flu active ingredients†

Maximum Strength



Nighttime



Severe Cold and Flu

• Relieves headache, fever, sore throat,



minor aches & pains, nasal/sinus



congestion & sinus pressure, sneezing, runny nose & cough

10 Softgels

Active Ingredients (in Each Softgel)

Acetaminophen 325mg



Dextromethorphan HBr 10mg



Doxylamine succinate 6.25mg



Phenylephrine HCl 5mg


Structured Label Content

Uses

• temporarily relieves common cold/flu symptoms



• nasal congestion

  • sinus congestion & pressure



• cough due to minor throat & bronchial irritation



• cough to help you sleep



• minor aches & pains



• headache



• fever

  • sore throat



• runny nose & sneezing



• reduces swelling of nasal passages



• temporarily restores freer breathing through the nose



• promotes nasal and/or sinus drainage

Section 50565-1 (50565-1)

Keep out of reach of children. 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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if



• you get nervous, dizzy or sleepless



• pain, nasal congestion, or cough gets worse or lasts 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

• excitability may occur, especially in children

• marked drowsiness may occur n avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

• alcohol, sedatives, and tranquilizers may increase drowsiness

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you have

• liver disease

• heart disease

• high blood pressure

• thyroid disease

• diabetes

• glaucoma

• cough that occurs with too much phlegm (mucus)

• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

• trouble urinating due to enlarged prostate gland

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,

ask a health professional before use.

Purpose

Pain reliever/fever reducer



Cough suppressant



Antihistamine



Nasal decongestant

Warnings

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 every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:



• skin reddening



• blisters



• rash



If a skin reaction 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
  • do not exceed 8 softgels per 24 hour
adults & children 12 years & over 2 softgels with water every 4 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

Drug Facts

Other Information (Other information)

• do not exceed 25°C (77°F)

Inactive Ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, sodium hydroxide*, titanium dioxide



* may contain this ingredient

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel

Compare to Vicks® NyQuil® Severe Cold & Flu active ingredients†

Maximum Strength



Nighttime



Severe Cold and Flu

• Relieves headache, fever, sore throat,



minor aches & pains, nasal/sinus



congestion & sinus pressure, sneezing, runny nose & cough

10 Softgels

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

Acetaminophen 325mg



Dextromethorphan HBr 10mg



Doxylamine succinate 6.25mg



Phenylephrine HCl 5mg


Advanced Ingredient Data


Raw Label Data

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