MUCUS RELIEF SINUS CONGESTION DAYTIME NIGHTTIME MAXIMUM STRENGTH- acetaminophen, guaifenesin, phenylephrine hcl, diphenhydramine hcl
Walgreen 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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Walgreens 44-615544-09-Delisted

Active ingredients (in each caplet)
(Sinus Day)

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Expectorant
Nasal decongestant

Active ingredients (in each caplet)
(Sinus Night)

Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Antihistamine
Nasal decongestant

Uses (Sinus Day)

temporarily relieves these common cold and flu symptoms:
- nasal congestion
- headache
- minor aches and pains
- sinus congestion and pressure
temporarily promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Uses (Sinus Night)

temporarily relieves these symptoms of hay fever and the common cold:
- sneezing
- runny nose
- headache
- sore throat
- nasal congestion
- minor aches and pains
temporarily relieves these additional symptoms of hay fever:
- itching of the nose or throat
- itchy, watery eyes

Warnings

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

more than 12 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. (Sinus Night only)

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.
if you have ever had an allergic reaction to this product or any of its ingredients (Sinus Night only)
with any other product containing diphenhydramine, even one used on skin (Sinus Night only)

Ask a doctor before use if you have

heart disease
liver disease
diabetes
thyroid disease
high blood pressure
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Sinus Day only)
cough that occurs with too much phlegm (mucus) (Sinus Day only)
a breathing problem such as emphysema or chronic bronchitis (Sinus Night only)
glaucoma (Sinus Night only)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers (Sinus Night only)

When using this product

do not exceed recommended dosage
excitability may occur, especially in children (Sinus Night only)
marked drowsiness may occur (Sinus Night only)
avoid alcoholic drinks (Sinus Night only)
alcohol, sedatives, and tranquilizers may increase drowsiness (Sinus Night only)
be careful when driving a motor vehicle or operating machinery (Sinus Night only)

Stop use and ask a 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
cough gets worse or lasts more than 7 days (Sinus Day only)
cough comes back or occurs with rash or headache that lasts (Sinus Day only)

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 (1-800-222-1222) 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

do not use more than directed (see overdose warning)
adults and children 12 years and over
- take 2 caplets every 4 hours
- do not take more than 12 caplets in 24 hours
children under 12 years: do not use

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients (Sinus Day)

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive ingredients (Sinus Night)

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin

Questions or comments?

1-800-426-9391

Principal Display Panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDED‡

DAYTIME • MAXIMUM STRENGTH
Mucus Relief
Sinus Congestion

Acetaminophen / Pain reliever
Guaifenesin / Expectorant
Phenylephrine HCl / Nasal Decongestant

10
CAPLETS

NIGHTTIME• MAXIMUM STRENGTH
Mucus Relief
Sinus Congestion

Acetaminophen / Pain reliever
Diphenhydramine HCl / Antihistamine
Phenylephrine HCl / Nasal Decongestant

10
CAPLETS

Compare to Maximum Strength Mucinex® SINUS-MAX™ Day & Night active ingredients‡‡

20 TOTAL CAPLETS

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

‡ Walgreens Pharmacist Survey Study, November 2014.
‡‡This product is not manufactured or distributed by
Reckitt Benckiser LLC, owner of the registered
trademark Maximum Strength Mucinex® SINUS-MAX™
Day & Night.

50844 REV0413A61554409

DISTRIBUTED BY:
WALGREEN CO.
200 WILMOT RD.,
DEERFIELD, IL 60015
100% SATISFACTION
GUARANTEED
walgreens.com
© 2016 Walgreen Co.

Walgreens 44-615544

MUCUS RELIEF SINUS CONGESTION DAYTIME NIGHTTIME MAXIMUM STRENGTH
acetaminophen, guaifenesin, phenylephrine hcl, diphenhydramine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0999

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0999-09	1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	06/30/2013	02/26/2021

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BLISTER PACK	10
Part 2	1 BLISTER PACK	10

Part 1 of 2

MUCUS RELIEF SINUS CONGESTION DAYTIME MAXIMUM STRENGTH
acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	44;615
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	06/30/2013

Part 2 of 2

MUCUS RELIEF SINUS CONGESTION NIGHTTIME MAXIMUM STRENGTH
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	44;544
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	09/19/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	06/30/2013	02/26/2021

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(0363-0999)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(0363-0999)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(0363-0999)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(0363-0999)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(0363-0999)

Revised: 7/2020

Document Id: e52a24a7-9c08-414e-9ba3-5d2bf368add8

Set id: dd839ce0-2411-4aa1-85cc-847bf142b6c2

Version: 8

Effective Time: 20200722

Walgreen Company

Walgreens 44-615544-09-Delisted

Active ingredients (in each caplet)(Sinus Day)

Purpose

Active ingredients (in each caplet)(Sinus Night)

Purpose

Uses (Sinus Day)

Uses (Sinus Night)

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredients (Sinus Day)

Inactive ingredients (Sinus Night)

Questions or comments?

Principal Display Panel

Active ingredients (in each caplet)
(Sinus Day)

Active ingredients (in each caplet)
(Sinus Night)