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

Day Time Night Time Sinus Relief by

Drug Labeling and Warnings

Day Time Night Time Sinus Relief by is a Otc medication manufactured, distributed, or labeled by Walgeens Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

DAY TIME NIGHT TIME SINUS RELIEF 
acetaminophen, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1019

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1019-03	1 in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 BLISTER PACK	32
Part 2	2 BLISTER PACK	16

Part 1 of 2

DAY TIME SINUS RELIEF 
acetaminophen, phenylephrine hcl capsule, liquid filled

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONES (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	48A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2013

Part 2 of 2

NIGHT TIME SINUS RELIEF 
acetaminophen, doxylamine succinate, phenylephrine hcl, capsule, liquid filled

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONES (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	47A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2013

Labeler - Walgeens Company (008965063)