Daytime Nighttime Sinus Relief by Hy-Vee Drug Facts

Daytime Nighttime Sinus Relief by

Drug Labeling and Warnings

Daytime Nighttime Sinus Relief by is a Otc medication manufactured, distributed, or labeled by Hy-Vee. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DAYTIME NIGHTTIME SINUS RELIEF- acetaminophen, doxylamine succinate, phenylephrine hcl 
Hy-Vee

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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Drug Facts

Active ingredients for Sinus Nighttime (in each softgel)

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Active ingredients for Sinus Daytime (in each softgel)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purposes for Nighttime

Pain reliever

Antihistamine

Nasal decongestant

Purposes for Daytime

Pain reliever

Nasal decongestant

Uses

  • temporarily relieves nasal and sinus symptoms:
    • sinus pain
    • headache
    • runny nose and sneezing (Nighttime Sinus only)
    • nasal and sinus congestion

Warnings

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

  • more than 4 doses in 24 hours, which is the maximum daily amount 
  • with any other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using these 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.                 

Ask a doctor before using if you have

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

Ask a doctor or pharmacist before use if you are

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

When using this product

  • do not use more than directed, in addition when using Nighttime Sinus:
  • 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, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

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

These may be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose could cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see Overdose warning) 
  • do not exceed 4 doses in 24 hours
  • when using other Nighttime and Daytime products, carefully read each label to ensure correct dosing
 ageNighttime Sinus Daytime Sinus 
 adults and children 12 years of age and over take 2 softgels with water every 4 hours  take 2 softgels with water every 4 hours 
 children 4 to under 12 years of age ask a doctor  ask a doctor
 children under 4 years of age do not use do not use
  • if taking Nighttime and Daytime softgels limit total to 4 doses per day

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

Inactive ingredients 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 1-800-289-8343 Monday-Friday 9AM-4PM CST

Principal Display Panel

*Compare to the Active Ingredients of Vicks® DayQuil® Sinex® and Vicks® NyQuil® Sinex®

Sinus Relief

Day

Day Non-Drowsy Contains 2 Medicines:

Sinus Headache & Pain - Acetaminophen

Sinus Pressure & Congestion - Phenylephrine HCl

Softgels**

Night

Night Contains 3 Medicines:

Sinus Headache & Pain - Acetaminophen

Runny Nose - Doxylamine succinate

Sinus Pressure & Congestion - Phenylephrine HCl

Softgels**

**Liquid-Filled Capsules

WHEN USING DAYTIME AND NIGHTTIME PRODUCTS, CAREFULLY READ THE LABELING TO ENSURE CORRECT DOSING

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® Sinex® and Vicks® NyQuil® Sinex®.

DISTRIBUTED BY HY-VEE, INC.

5820 WESTOWN PARKWAY

WEST DES MOINES, IA 50266

www.hy-vee.com

PRODUCT OF CANADA

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Acetaminophen 325 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg

Hy-Vee Sinus Relief Day / Night Softgels

DAYTIME NIGHTTIME SINUS RELIEF 
acetaminophen, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42507-092
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42507-092-481 in 1 CARTON; Type 0: Not a Combination Product11/30/201312/31/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 16 
Part 24 BLISTER PACK 32 
Part 1 of 2
NIGHTTIME SINUS RELIEF 
acetaminophen, doxylamine succinate, phenylephrine hcl capsule
Product Information
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)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code 47A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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 FINALpart34111/30/201312/31/2019
Part 2 of 2
DAYTIME SINUS RELIEF 
acetaminophen, phenylephrine hcl capsule
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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code 48A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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 FINALpart34111/30/201312/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/30/201312/31/2019
Labeler - Hy-Vee (006925671)

Revised: 12/2018
 
Hy-Vee