SINUS RELIEF DAYTIME NIGHTTIME- acetaminophen, doxylamine succinate, phenylephrine hcl kit

Sinus Relief Daytime Nighttime by

Drug Labeling and Warnings

Sinus Relief Daytime Nighttime by is a Otc medication manufactured, distributed, or labeled by WALGREEN CO., Accucaps Industries, Ltd., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each liquid cap)

Acetaminophen 325 mg
Phenyelphrine HCl 5 mg

Purpose

Pain reliever
Nasal decongestnat 

Uses

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

Warnings

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 acetaminohen
• 3 or more alcoholic drinks every ay 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
• 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 exceed recommended dosage

Stop use and ask a doctor if

• redness or swellling 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.  Quickmedical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take only as recommended (see overdose warning)
• adults and children 12 years and over
  • 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number
• for better identification, keep liquid caps in carton until used

Inactive ingredients

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

Active ingredient (in each liquid cap)

Acetaminophen 325 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Antihistamine
Nasal decongestant 

Uses

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

Warnings

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 acetaminohen
• 3 or more alcoholic drinks every ay 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

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• glaucoma
• thyroid disease
• diabetes
• 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, expecially 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 a doctor if

• redness or swellling 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.  Quickmedical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take only as recommended (see overdose warning)
• adults and children 12 years and over
  • 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number
• for better identification, keep liquid caps in carton until used

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

COMBO PACK

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC: 0363-0555-22

NON-DROWSY DAYTIME
Sinus Relief
Acetaminophen /
Sinus Headache & Pain
Phenylephrine HCl /
Sinus Pressure
& Congestion

32 LIQUID CAPS

NGHTTIME
Sinus Relief
Acetaminophen /
Sinus Headache & Pain
Doxylamine Succinate /
Runny Nose
Phenylephrine HCl /
Sinus Pressure & Congestion

16 LIQUID CAPS

Compare to Vicks® DayQuil® & NyQuil® Sinex® Sinus Relief LiquiCaps® active ingredientsǂǂ

48 TOTAL LIQUID CAPS

ǂWalgreens Pharmacist Survey Study, November 2010
ǂǂThis product is not manufactured  or distributed by Novartis Consumer Health, owner of the registered trademark Excedrin® Extra Strength Tablets.

50844    REV1012.553/554A22

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

Walgreens 44-553/554

INGREDIENTS AND APPEARANCE

SINUS RELIEF DAYTIME NIGHTTIME 
acetaminophen, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0555

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0555-22	1 in 1 PACKAGE, COMBINATION

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

Part 1 of 2

NON DROWSY DAYTIME SINUS RELIEF 
acetaminophen, phenylephrine hcl capsule

Product Information
Item Code (Source)	NDC: 0363-0000
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
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	17mm
Flavor	MINT	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	07/15/2005

Part 2 of 2

NIGHTTIME SINUS RELIEF 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule

Product Information
Item Code (Source)	NDC: 0363-0009
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
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	17mm
Flavor	MINT	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	07/21/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/21/2005

Labeler - WALGREEN CO. (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries, Ltd.		248441727	MANUFACTURE(0363-0555, 0363-0000, 0363-0009)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0363-0555, 0363-0000, 0363-0009)