DAYTIME SINUS RELIEF AND NIGHTTIME SINUS RELIEF- acetaminophen, doxylamine succinate, phenylephrine hydrochloride 
PuraCap Pharmaceutical LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Daytime Sinus Relief and Nighttime Sinus Relief

Active ingredients for Nighttime Sinus (in each softgel)

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Active ingredients for Daytime Sinus (in each softgel)

Acetaminophen 325 mg
Phenylephrine hydrochloride 5 mg

Purposes

Nighttime Sinus Relief

Pain reliever/Fever reducer

Antihistamine

Nasal decongestant

Purposes

Daytime Sinus Relief

Pain reliever/Fever reducer

Nasal decongestant

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 congestion
    • sinus congestion & pressure

Warnings

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

  • 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

  • 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

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

When using this product

  • 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

  • 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  

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

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 & for children even if you do not notice any signs or symptoms.

Directions

  • 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

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

Inactive ingredients

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?

Call toll free: 1-855-215-8180

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 48ct

DAYTIME SINUS RELIEF AND NIGHTTIME SINUS RELIEF 
acetaminophen, doxylamine succinate, phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-114
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51013-114-131 in 1 CARTON; Type 0: Not a Combination Product08/02/201612/31/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 BLISTER PACK 32 
Part 22 BLISTER PACK 16 
Part 1 of 2
DAYTIME SINUS RELIEF 
acetaminophen, phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colororange (clear) Scoreno score
Shapecapsule (oblong) Size19mm
FlavorImprint Code PC12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 CARTON
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/02/201612/31/2019
Part 2 of 2
NIGHTTIME SINUS RELIEF 
acetaminophen, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorblue (clear) Scoreno score
Shapecapsule (oblong) Size20mm
FlavorImprint Code PC13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 CARTON
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/02/201612/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/02/201612/31/2019
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd421293287manufacture(51013-114) , analysis(51013-114)

Revised: 3/2018
Document Id: d5317ab7-9040-4a2a-bd6e-570abd6afc9e
Set id: 53f854eb-e2a5-4b0f-a7de-4c4f117d3fdf
Version: 2
Effective Time: 20180321
 
PuraCap Pharmaceutical LLC