Maximum Strength Nighttime Severe Cold And Flu
c3d0b70f-d213-4e38-88ab-1c89d93a391d
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:53.157258 · Updated: 2026-03-14T23:09:57.827589