DAY TIME NIGHT TIME SINUS RELIEF- acetaminophen, doxylamine succinate, phenylephrine hcl 
Walgeens Company

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/Nighttime Sinus Relief Drug Facts

Active ingredient for DAYTIME (in each liquid cap)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Active ingredient for NIGHTTIME (in each liquid cap)

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose (DAYTIME ONLY)

Pain reliever

Nasal decongestant

Purpose (NIGHTTIME ONLY)

Pain reliever

Antihistamine

Nasal decongestant

Uses (DAYTIME ONLY)

  • temporarily relieves nasal and sinus symptoms: 
  • sinus pain
  • headache
  • nasal and sinus congestion

Uses (NIGHTTIME ONLY)

  • temporarily relieves nasal and sinus symptoms:
  • headache 
  • sinus pain
  • nasal and sinus congestion
  • runny nose and sneezing

Warnings (DAYTIME ONLY)

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

  • more than 12 liquid caps in 24 hours, which is the maximum daily amount 
  • with other drugs containing acetaminophen
  • 3 or more alcohol drinks every day 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.

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage

Stop use and ask doctor if

  • redness or swelling is present
  • nervousness, dizziness or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days 
  • new symptoms occur 

These could be signs of a serious condition.

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

Keep out of reach of children.

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

Warnings (NIGHTTIME ONLY)

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

  • more than 12 liquid caps in 24 hours, which is the maximum daily amount 
  • with other drugs containing acetaminophen
  • 3 or more alcohol drinks every day 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.

Ask a doctor before use if you have

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

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 exceed recommended dosage
  • excitability may occur, especially in children 
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask doctor if

  • nervousness, dizziness or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur 

These could be signs of a serious condition.

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

Keep out of reach of children.

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

Directions (DAYTIME ONLY)

  • take only as recommended(see overdose warning)
  • adults and children 12 years and over:
  • take 2 liquid caps with water every 4 hours
  • do not take more than 12 liquid caps in 24 hours
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Directions (NIGHTTIME ONLY)

  • take only as recommended(see overdose warning)
  • adults and children 12 years and over:
  • take 2 liquid caps with water every 4 hours
  • do not take more than 12 liquid caps in 24 hours
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

  • store at controlled room temperature 15°C to 30°C (59°F to 86°F)
  • see end flap for expiration date and lot number
  • for better identification, keep liquid caps in carton until used

Inactive ingredients (DAYTIME ONLY)

edible white ink, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

Inactive ingredients (NIGHTTIME ONLY)

edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol 

Questions

1-800-706-5575

Principal Display Panel

Combo Pack

SINUS RELIEF • NONDROWSY • DAYTIME

Acetaminophen/Sinus Headache & Pain

Phenylephrine HCl/Sinus Pressure & Congestion

32 LIQUID CAPS

SINUS RELIEF • NIGHTTIME

Acetaminophen/Sinus Headache & Pain/

Doxylamine Succinate/Runny Nose

Phenylephrine HCl/Sinus Pressure & Congestion

16 LIQUID CAPS

48 TOTAL LIQUID CAPS

day-night-sinus-relief-ctn

DAY TIME NIGHT TIME SINUS RELIEF 
acetaminophen, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1019
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1019-031 in 1 CARTON; Type 1: Convenience Kit of Co-Package03/01/201308/14/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 BLISTER PACK 32 
Part 22 BLISTER PACK 16 
Part 1 of 2
DAY TIME SINUS RELIEF 
acetaminophen, phenylephrine hcl 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, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize20mm
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 finalpart34103/01/201308/14/2020
Part 2 of 2
NIGHT TIME SINUS RELIEF 
acetaminophen, doxylamine succinate, phenylephrine hcl, capsule, liquid filled
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, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize20mm
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 finalpart34103/01/201308/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/201308/14/2020
Labeler - Walgeens Company (008965063)

Revised: 8/2020
 
Walgeens Company