Severe Sinus Congestion And Cough
FDA Label NDC 0363-9890

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Severe Sinus Congestion And Cough (NDC 0363-9890). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning, allergy alert, sore throat warning, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

SEVERE SINUS CONGESTION & COUGH DAYTIME SOFTGELS

Drug Facts

SEVERE SINUS CONGESTION & COUGH NIGHTTIME SOFTGELS

Drug Facts

Otc - Purpose

Active Ingredients (in each softgel)Purpose
Acetaminophen 325 mgPain reliever / Fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant
Active Ingredients (in each softgel)Purpose
Acetaminophen 325 mgPain reliever / Fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

  • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • cough
    • nasal congestion
    • sore throat
    • temporarily relieves sinus congestion and pressure
    • helps clear nasal passages and shrinks swollen membranes
    • temporarily reduces fever
      • temporarily relieves these symptoms due to a cold or flu:
        • minor aches and pains
        • headache
        • nasal congestion
        • cough
        • sore throat
        • runny nose
        • sneezing
        • temporarily reduces fever

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 10 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

    • This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 10 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.

    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.

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.

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.
  • If you have ever had an allergic reaction to this product or any of its ingredients
  • In children under 12 years of age

Ask A Doctor Before Use If You Have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough with excessive phlegm(mucus)
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • cough with excessive phlegm (mucus)
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking the blood thinning drug warfarin
    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

Otc - When Using

When using this product do not exceed recommended dosage

Stop Use And Ask A Doctor If

  • pain, cough or nasal congestion gets 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.
  • nervousness, dizziness, or sleeplessness occurs.
    • pain, cough, or nasal congestion 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.
    • nervousness, dizziness, or sleeplessness occurs

Otc - Pregnancy Or Breast Feeding

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

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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.

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. 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.

Directions

  • take only as recommended (see overdose warning)
  • do not take more than recommended dose
  • adults and children 12 years and over :take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor
  • children under 12 years: do not use
    • do not take more than the recommended dose
    • adults and children 12 years and over: take 2 softgels with water every 4 hours.

      • Do not exceed 10 softgels in 24 hours or as directed by a doctor.

      • children under 12 years: do not use

Other Information

  • store at room temperature. Avoid excessive heat.
    • store at room temperature. Avoid excessive heat.

Inactive Ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

D&C Yellow #10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

1-888-333-9792

Otc - Do Not Use

Do not use to sedate children.

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.
  • in children under 12 years of age
  • If you have ever had an allergic reaction to this product or any of its ingredients

When Using This Product

  • do not exceed recommended dosage
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Principal Display Panel - Kit Carton

DAY & NIGHT PACK

NDC 0363-9890-20

Walgreens

Compare to Alka-Seltzer PLUS® Day and Night Severe Sinus Congestion & Cough active ingredients‡‡

DAYTIMENON-DROWSY

Severe Sinus
Congestion & Cough

ACETAMINOPHEN/

PAIN RELIEVER/FEVER REDUCER

DEXTROMETHORPHAN HBr/COUGH SUPPRESSANT

PHENYLEPHRINE HCL/NASAL CONGESTANT

  • Pain reliever, fever reducer,

    •     cough suppressant & 
        nasal decongestant

    Actual Size

    12 SOFTGELS

    NIGHTTIME

    Severe Sinus
    Congestion & Cough

    ACETAMINOPHEN/

    PAIN RELIEVER/FEVER REDUCER

    DEXTROMETHORPHAN HBr/COUGH SUPPRESSANT

    DOXYLAMINE SUCCINATE/ANTIHISTAMINE

    PHENYLEPHRINE HCL/NASAL DECONGESTANT

    • Relieves sinus congestion & pressure,
      headache, runny
      nose, sneezing &
      cough

      • Actual Size

      8 SOFTGELS

      20 TOTAL SOFTGELS

* Please review the disclaimer below.