Skip to Content

NightTime Sinus Relief

Medically reviewed by Drugs.com. Last updated on Nov 7, 2019.

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DOXYLAMINE SUCCINATE 6.25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
NDC Code: 53345-013

NightTime Sinus Relief capsule, liquid filled

Active ingredients (in each capsule)

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 taking NIGHTTIME and 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

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

PRINCIPAL DISPLAY PANEL - Shipping Label

NightTime Sinus Relief Capsules

Quantity : 4000 Capsules
NDC. No : 53345-013-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

NIGHTTIME SINUS RELIEF 
acetaminophen, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-013
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorblueScoreno score
ShapeCAPSULE (oblong) Size21mm
FlavorImprint CodePC13
Contains    
Packaging
#Item CodePackage Description
1NDC:53345-013-011 BAG in 1 BOX
14000 CAPSULE, LIQUID FILLED in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/15/2013
Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(53345-013), ANALYSIS(53345-013)

 
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

More about acetaminophen / doxylamine / phenylephrine

Related treatment guides