NIGHT TIME SINUS RELIEF- acetaminophen, phenylephrine hydrochloride, doxylamine succinate capsule, liquid filled 
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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Night Time Sinus Relief

Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Uses

temporarily relieves nasal and sinus symptoms:

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take


Allergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:

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  

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

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

When using this product

  • do not use more than directed
  • 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

  • redness or swelling is present
  • you get nervous, dizzy or sleepless
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • symptoms do not get better within 7 days or are accompanied by a fever

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

Keep out of reach of children.  

Overdose warning

Taking more than directed can cause serious health problems. 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

adults & children 12 yrs and over

take 2 softgels with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

Inactive ingredients

FD&C blue #1, 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

Night Time Sinus Relief 16 SOFTGELS

NDC 51013-186-14

*Compare to the active ingredients in Vicks® NyQuil® Sinex® LiquiCaps®

Carton Label

NIGHT TIME SINUS RELIEF 
acetaminophen, phenylephrine hydrochloride, doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-186
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (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
1NDC:51013-186-142 in 1 CARTON07/15/2016
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 finalpart34107/15/2016
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd421293287manufacture(51013-186) , analysis(51013-186)

Revised: 1/2020
Document Id: 5e2b9d63-1ea7-4630-b6a3-16374061a6d4
Set id: 649f429a-ba62-4ef0-9c7f-940bbf18dbf0
Version: 2
Effective Time: 20200103
 
PuraCap Pharmaceutical LLC