Acetaminophen Dextromethorphan HBr Doxylamine succinate Phenylephrine HCl

Manufacturer
CVS PHARMACY, INC
Effective date
2017-10-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:09:39

Label at a glance#

ProductAcetaminophen Dextromethorphan HBr Doxylamine succinate Phenylephrine HCl
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure36 sections

Indications and uses

temporarily relieves these symptoms due to cold and flu: sneezing itching of the nose, throat or watery eyes due to hay fever cough nasal congestion sinus congestion and pressure sore throat head ache minor aches and pains helps clear nasal passages and shrinks swollen membranes temporarily reduces fever

Dosage and administration

Do not take more than the recommended dose adults & children under 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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Severe Sinus Congestion and Cough Relief Day

(in each softgel)

Acetaminophen325 mg
Dextromethorphan Hydrobromide10 mg
Phenylephrine Hydrochloride5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to cold and flu:

  • sneezing
  • itching of the nose, throat or watery eyes due to hay fever
  • cough
  • nasal congestion
  • sinus congestion and pressure
  • sore throat
  • head ache
  • minor aches and pains

helps clear nasal passages and shrinks swollen membranes

temporarily reduces fever

Liver warning

WARNINGS SECTION

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

WARNINGS SECTION

acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

If a skin or allergic reaction occurs, stop use and seek medical help right away.

Sore throat warning

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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 ever had an allergic reaction to this product or any of its ingredients
  • in children 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough with excess phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

when using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 head ache that lasts for 1 week, these could be the signs of serious condition
  • nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact 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

DOSAGE & ADMINISTRATION SECTION

Do not take more than the recommended dose

adults & children under 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

OTHER SAFETY INFORMATION

  • store at controlled room temperature, 15 – 30°C (59 – 86°F)
  • Parents: Learn about teen medicine abuse, WWW.StopMedicineAbuse.org

Inactive ingredients

INACTIVE INGREDIENT SECTION

allura red AC, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, glycerol, polyethylene glycol, povidone, propylene glycol, purified water, sorbital sorbitan solution, sunset yellow FCF

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Severe Sinus Congestion & Cough Relief Night

(in each softgel)

Acetaminophen325 mg
Dextromethorphan Hydrobromide10 mg
Doxylamine Succinate6.25 mg
Phenylephrine Hydrochloride5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to cold and flu:

  • sneezing
  • itching of the nose, throat or watery eyes due to hay fever
  • cough
  • nasal congestion
  • sinus congestion and pressure
  • sore throat
  • headache
  • minor aches and pains
  • runny nose

helps clear nasal passages and shrinks swollen membranes
temporarily reduces fever

Liver warning

WARNINGS SECTION

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

WARNINGS SECTION

acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

If a skin or allergic reaction occurs, stop use and seek medical help right away.

Sore throat warning

WARNINGS SECTION

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 to sedate children.

WARNINGS SECTION

Do not use to sedate children.

Do not use

OTC - DO NOT USE SECTION

  • 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 ever had an allergic reaction to this product or any of its ingredients
  • in children 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough with excess 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 occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dose
  • may cause marked drowsiness
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving motor vehicles or operating machinery
  • may cause excitability in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 head ache that lasts for 1 week, these could be the signs of serious condition
  • nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact 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

DOSAGE & ADMINISTRATION SECTION

Do not take more than the recommended dose

adults & children under 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

OTHER SAFETY INFORMATION

  • store at controlled room temperature, 15 – 30°C (59 – 86°F)
  • Parents: Learn about teen medicine abuse, WWW.StopMedicineAbuse.org

Inactive ingredients

INACTIVE INGREDIENT SECTION

brilliant blue FCF, gelatin, glycerol, polyethylene glycol, povidone, propylene glycol, purified water, sorbital sorbitan solution, quilolline yellow WS.

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20 count softgels20 count softgels

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-30369842-303-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f6f302fb-088c-ffa7-e053-6394a90a845f5bffd877-8096-5fc5-e053-2a91aa0a8ead2023-03-15WarningsExact identifier
spl set id: 5bffd877-8096-5fc5-e053-2a91aa0a8ead

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.