SINUS RELIEF DAYTIME NIGHTTIME- acetaminophen, doxylamine succinate, phenylephrine hcl 
WALGREEN CO.

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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Walgreens 44-553554

Active ingredients (in each liquid cap)

Acetaminophen 325 mg
Phenyelphrine HCl 5 mg

Purpose

Pain reliever
Nasal decongestnat 

Uses

Warnings

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

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

Other information

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

Warnings

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

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

Other information

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

Walgreens 44-553/554

SINUS RELIEF DAYTIME NIGHTTIME 
acetaminophen, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0555
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0555-221 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 BLISTER PACK 32   in 4 
Part 22 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 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
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorMINTImprint Code 48A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/15/2005
Part 2 of 2
NIGHTTIME SINUS RELIEF 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule
Product Information
Item Code (Source)NDC:0363-0009
Route of 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
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize17mm
FlavorMINTImprint Code 47A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/21/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/21/2005
Labeler - WALGREEN CO. (008965063)
Establishment
NameAddressID/FEIBusiness Operations
Accucaps Industries, Ltd.248441727MANUFACTURE(0363-0555, 0363-0000, 0363-0009)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(0363-0555, 0363-0000, 0363-0009)

Revised: 2/2013
Document Id: 99eb5e5b-4aa9-4fdb-b7bd-53b0b0765e4c
Set id: 3bc85233-9365-40bb-b2bd-07b696853131
Version: 4
Effective Time: 20130220
 
WALGREEN CO.