FDA.reportPublic FDA data

Daytime Sinus Relief and Nighttime Sinus Relief

Manufacturer
PuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
Effective date
2018-03-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:00:45

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 hrs Age Daytime Sinus Nighttime Sinus adults and children 12 yrs & over 2 softgels with water every 4 hrs 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor ask a doctor children under 4 yrs 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

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.

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 hrs

Age

Daytime Sinus

Nighttime Sinus

adults and children 12 yrs & over

2 softgels with water every 4 hrs

2 softgels with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

ask a doctor

children under 4 yrs

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 toll free: 1-855-215-8180

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Daytime Sinus Relief and Nighttime Sinus Relief   48 SOFTGELS

NDC 51013-114-13

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

CVS Daytime and Nighttime Sinus Relief 48ctCVS Daytime and Nighttime Sinus Relief 48ct

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
51013-11451013-114-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT

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
d5317ab7-9040-4a2a-bd6e-570abd6afc9e53f854eb-e2a5-4b0f-a7de-4c4f117d3fdf2018-03-21WarningsExact identifier
spl id: d5317ab7-9040-4a2a-bd6e-570abd6afc9e
spl set id: 53f854eb-e2a5-4b0f-a7de-4c4f117d3fdf

Reported adverse events (FAERS/openFDA)#

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