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

Day Time and Night Time Sinus and Congestion by

Drug Labeling and Warnings

Day Time and Night Time Sinus and Congestion by is a Otc medication manufactured, distributed, or labeled by Walgreens Company, Apotex Inc., Accucaps Industries Limited, Accucaps Industries Limited Strathroy, Legacy Pharmaceutical Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients for DAYTIME ONLY (in each LiquidCap)

Acetaminophen

Phenylephrine HCI

Active ingredients for NIGHTTIME (in each LiquidCap)

Acetaminophen

Doxylamine succinate

Phenylephrine hydrochloride

Purpose (DAYTIME ONLY)

Pain reliever/fever reducer

Nasal decongestant

Purpose (NIGHTTIME ONLY)

Pain reliever/Fever reducer

Antihistamine

Nasal decongestant

Uses (DAYTIME ONLY)

temporarily relieves symptoms due to common cold:

• minor aches and pains
• headache
• fever
• nasal and sinus congestion
• sinus congestion & pressure

Uses (NIGHTTIME ONLY)

temporarily relieves symptoms due to common cold:

• minor aches and pains
• headache
• fever
• runny nose and sneezing  
• nasal congestion
• sinus congestion & pressure

Warnings (DAYTIME ONLY)

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 for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic 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.
• to make a child sleep

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask doctor if

• 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
• you get nervous, dizzy or sleepless

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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 4 doses in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic 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.
• to make a child sleep

Ask a doctor before use if you have

• liver disease
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• glaucoma
• trouble urinating due to an enlarged prostate gland

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.  
• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• excitability may occur, especially in children
• alcohol, sedatives & tranquilizers may increase drowsiness

Stop use and ask doctor if

• 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
• you get nervous, dizzy or sleepless

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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 directed
• do not exceed 4 doses per 24 hrs 

• adults & children 12 yrs & over: 2 LiquiCaps with water every 4 hrs
• children 4 to under 12 yrs: ask a doctor
• children under 4 yrs: do not use

Directions (NIGHTTIME)

• take only as directed
• do not exceed 4 doses per 24 hrs 

• adults & children 12 yrs & over: 2 LiquiCaps with water every 4 hrs
• children 4 to under 12 yrs: ask a doctor
• children under 4 yrs: do not use

Other Information

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

Inactive ingredients (DAYTIME ONLY)

edible white ink, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol –may contain this ingredient

Inactive ingredients (NIGHTTIME)

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

Inactive ingredients (NIGHTTIME)

D&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sortitian, sorbitol

Questions or comments?

1-800-706-5575

Principal Display Panel

Combo Pack

NON-DROWSY DAYTIME

Sinus & Congestion

Acetaminophen / Sinus Headache

& Pain / Phenylephrine HCl /

Sinus Pressure & Congestion

32 LIQUID CAPS

NIGHTTIME

Sinus & Congestion

Acetaminophen / Sinus Headache

& Pain / Doxylamine Succinate /

Runny Nose / Phenylephrine HCl /

Sinus Pressure & Congestion

16 LIQUID CAPS

Compare to Vicks® QlearQuil™ Day/Night Sinus & Congestion Liquicaps®#

48 TOTAL LIQUID CAPS

INGREDIENTS AND APPEARANCE

DAY TIME AND NIGHT TIME SINUS AND CONGESTION 
acetaminophen, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1035

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1035-03	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package

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

Part 1 of 2

DAY TIME SINUS AND CONGESTION 
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)
POVIDONE (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	95A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		32 in 1 BLISTER PACK; Type 0: Not a Combination Product

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 AND CONGESTION 
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	GREEN	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	35A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		16 in 1 BLISTER PACK; Type 0: Not a Combination Product

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	09/01/2014

Labeler - Walgreens Company (008965063)

Registrant - Apotex Inc. (209429182)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Limited		248441727	analysis(0363-1035) , manufacture(0363-1035)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Limited Strathroy		243944050	analysis(0363-1035) , manufacture(0363-1035)

Establishment
Name	Address	ID/FEI	Business Operations
Legacy Pharmaceutical Packaging		969852743	pack(0363-1035)