Sinus and Headache Day Night

Manufacturer
GOODSENSE
Effective date
2022-12-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:45:21

Label at a glance#

ProductSinus and Headache Day Night
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE
Label structure11 sections

Indications and uses

■ temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:    ■ headache    ■ sinus congestion and pressure    ■ nasal congestion    ■ minor aches and pains ■ helps decongest sinus openings and passages ■ promotes sinus drainage ■ helps clear nasal passages ■ temporarily reduces fever   

Dosage and administration

■ do not take more than directed (see overdose warning) ■ do not take Day and Night caplets at the same time ■ do not take more than a total of 10 caplets in 24 hours adults and children 12 years and over take 2 caplets every 4 hours swallow whole; do not crush, chew, or dissolve children under 12 years ask a doctor

Storage and handling

■ store between 20-25ºC (68-77ºF) in a dry place ■ retain carton for complete product information and warnings

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

SINUS + HEADACHE DAY

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each day caplet)  Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
   ■ headache
   ■ sinus congestion and pressure
   ■ nasal congestion
   ■ minor aches and pains
■ helps decongest sinus openings and passages
■ promotes sinus drainage
■ helps clear nasal passages
■ temporarily reduces fever   

SPL UNCLASSIFIED SECTION

SINUS + HEADACHE NIGHT

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each night caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
   ■ headache
   ■ sinus congestion and pressure
   ■ nasal congestion
   ■ runny nose and sneezing
   ■ minor aches and pains
■ helps decongest sinus openings and passages
■ promotes sinus drainage
■ helps clear nasal passages
■ temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product

Allergy alert

SPL UNCLASSIFIED SECTION

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.

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 have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ liver disease
■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes
■ trouble urinating due to an enlarged prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
■ glaucoma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

■ do not exceed recommended dosage
In addition, when using Sinus + Headache Night:
■ excitability may occur, especially in children
■ drowsiness may occur
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ avoid alcoholic drinks
■ be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ nervousness, dizziness, or sleeplessness occur
■ pain 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
These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning

SPL UNCLASSIFIED SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

■ do not take more than directed (see overdose warning)

■ do not take Day and Night caplets at the same time
■ do not take more than a total of 10 caplets in 24 hours

adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole; do not crush, chew, or dissolve
children under 12 years
  • ask a doctor

Other information

STORAGE AND HANDLING SECTION

■ store between 20-25ºC (68-77ºF) in a dry place
■ retain carton for complete product information and warnings

Inactive ingredients

INACTIVE INGREDIENT SECTION

SINUS + HEADACHE DAY

SPL UNCLASSIFIED SECTION

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

SINUS + HEADACHE NIGHT

SPL UNCLASSIFIED SECTION

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, flavor, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOODSENSE®

NDC 50804-149-02

Pain Relief

Sinus + Headache

Cool Taste Instant Cooling Sensation

For Adults

Acetaminophen/ Pain Reliever•Fever Reducer 

Phenylephrine HCl/Nasal Decongestant

Chlorpheniramine Maleate*/Antihistamine*

Day

• Sinus Headache

• Sinus Pressure

• Nasal Congestion

Actual Size

12 CAPLETS

Night

• Sinus Headache

• Sinus Pressure

• Nasal Congestion

• Runny Nose*

*antihistamine in Nighttime Only

Actual Size

8 CAPLETS image descriptionimage description

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50804-14950804-149-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 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
ef428260-1982-77f6-e053-2a95a90a4b1aa793000b-3ef2-5662-e053-2a95a90ad0da2022-12-07WarningsExact identifier
spl id: ef428260-1982-77f6-e053-2a95a90a4b1a
spl set id: a793000b-3ef2-5662-e053-2a95a90ad0da

Reported adverse events (FAERS/openFDA)#

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