MULTI-SYMPTOM NIGHTTIME SINUS RELIEF- acetaminophen, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled 
PuraVation Pharmaceuticals Inc

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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MULTI-SYMPTOM NIGHTTIME SINUS RELIEF capsule, liquid filled

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 & sinus symptoms:

  • sinus pain 
  • headache  
  • nasal & sinus congestion 
  • runny nose & sneezing

Warnings

Liver warning

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

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

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

  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hrs

Adults & children 12 yrs & over

 2 softgels with water every 4 hrs

Children 4 to under 12 yrs

 ask a doctor

children under 4 yrs

 do not use
  • when using other NIGHTTIME or DAYTIME products, carefully read each label to insure correct dosing

Other information

  • store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

FD&C Blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, titanium dioxide

PRINCIPAL DISPLAY PANEL - 20 Softgels Carton

Sinus Relief NIGHTTIME

NDC 76270-114-08

*Compare to the active ingredients in VICKS®NYQUIL®SINEX®

Acetaminophen

Pain Reliever

Doxylamine Succinate

Antihistamine

Phenylephrine

Nasal Decongestant

Relieves:

  • Sinus Headache and Pain
  • Runny Nose
  • Sinus Congestion and Pressure

SEE NEW WARNINGS INFORMATION

20 softgels

PRINCIPAL DISPLAY PANEL - Shipping Label

MULTI-SYMPTOM NIGHTTIME SINUS RELIEF 
acetaminophen, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76270-114
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 GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULE (oblong) Size21mm
FlavorImprint Code PC13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76270-114-082 in 1 CARTON09/15/201312/30/2016
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/15/201312/30/2016
Labeler - PuraVation Pharmaceuticals Inc (968385034)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(76270-114) , ANALYSIS(76270-114)

Revised: 12/2016
 
PuraVation Pharmaceuticals Inc