Daytime Sinus Relief and Nighttime Sinus Relief

Manufacturer
Chain Drug Marketing Association Inc. | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
Effective date
2019-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:35

Label at a glance#

ProductDaytime Sinus Relief and Nighttime Sinus Relief
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure11 sections

Indications and uses

temporarily relieves symptoms due to the common cold minor aches and pains headache fever runny nose and sneezing (Nighttime only) nasal congestion sinus congestion & pressure temporarily relieves symptoms due to hay fever or other upper respiratory allergies minor aches and pains headache runny nose and sneezing (Nighttime only) itching of the nose or throat, and itchy, watery eyes (Nighttime only) nasal congesti...

Dosage and administration

take only as directed do not exceed 4 doses per 24 hours Age Daytime Sinus Nighttime Sinus adults and children 12 years and over 2 softgels with water every 4 hours 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor ask a doctor children under 4 years do not use do not use

Storage and handling

store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Label contents#

Full prescribing information#

Active ingredients for Nighttime Sinus (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Active ingredients for Daytime Sinus (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Phenylephrine hydrochloride 5 mg

Purposes

OTC - PURPOSE SECTION

Nighttime Sinus Relief

Pain reliever/Fever reducer

Antihistamine

Nasal decongestant

Purposes

OTC - PURPOSE SECTION

Daytime Sinus Relief

Pain reliever/Fever reducer

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves symptoms due to the common cold
    • minor aches and pains
    • headache
    • fever
    • runny nose and sneezing (Nighttime only)
    • nasal congestion
    • sinus congestion & pressure
  • temporarily relieves symptoms due to hay fever or other upper respiratory allergies
    • minor aches and pains
    • headache
    • runny nose and sneezing (Nighttime only)
    • itching of the nose or throat, and itchy, watery eyes (Nighttime only)
    • nasal congestion
    • sinus congestion & pressure

Warnings

WARNINGS SECTION

Liver warning

These products contain 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

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. 
  • to make a child sleep (Nighttime only)    

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease      
  • heart disease              
  • thyroid disease
  • diabetes  
  • high blood pressure  
  • glaucoma (Nighttime only)             
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)  
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers (Nighttime only)             
  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed, in addition when using Nighttime Sinus and Congestion:
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives & tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain or nasal congestion gets worse or last more than 7 days            
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present 
  • new symptoms occur
  • you get nervous, dizzy or sleepless  

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

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed
  • do not exceed 4 doses per 24 hours

Age

Daytime Sinus

Nighttime Sinus

adults and children 12 years and over

2 softgels with water every 4 hours

2 softgels with water every 4 hours

children 4 to under 12 years

ask a doctor

ask a doctor

children under 4 years

do not use

do not use

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Nighttime Sinus: FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink

Daytime Sinus: FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink

Questions or comments?

OTC - QUESTIONS SECTION

Call 248-449-9300

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CDMA Daytime Sinus Relief and Nighttime Sinus Relief 48 SOFTGELS

NDC 63868-464-48

Compare to the active ingredients in Vicks® QlearQuilTM Daytime Sinus & Congestion and Nighttime Sinus & Congestion*

Carton Label 1Carton Label 1

Carton Label 2Carton Label 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2634822{1 (acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCK2
26348221 daytime (acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) PackPSN2
1052647acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN2
1052670acetaminophen 325 MG / phenylephrine HCl 5 MG Oral CapsulePSN2
1052647acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2
1052670acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2
26348221 daytime (acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) PackSY2
1052647APAP 325 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY2
1052670APAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-464-482025-01-30C16284748780-12cef2736-900a-d83d-e063-dadaa90ab31fDaytime Sinus Relief and Nighttime Sinus Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-464-48Daytime Sinus Relief and Nighttime Sinus Relief1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-464DAYTIME SINUS RELIEF AND NIGHTTIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT [CHAIN DRUG MARKETING ASSOCIATION INC.]2Legacy NDC, 1 package rows20191231_d538445e-a47d-4983-844f-38aa303d11fd.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-46463868-464-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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
6f600ad5-ad1f-479f-9754-1dc6746a60aad538445e-a47d-4983-844f-38aa303d11fd2019-12-30WarningsExact identifier
spl id: 6f600ad5-ad1f-479f-9754-1dc6746a60aa
spl set id: d538445e-a47d-4983-844f-38aa303d11fd

Reported adverse events (FAERS/openFDA)#

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