MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
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 44-648-Discontinued

Active ingredients (in each caplet)

Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Cough suppressant
Expectorant
Nasal decongestant

Uses

temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Do not use

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

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
symptoms do not get better within 7 days or occur with fever
persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache

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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

do not take more than 12 caplets in any 24-hour period
adults and children 12 years and over: take 2 caplets every 4 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)
use by expiration date on package

Inactive ingredients

corn starch, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDED‡

NDC 0363-6480-09

MULTI-SYMPTOM
MAXIMUM STRENGTH

Mucus Relief

Severe Congestion & Cough

Dextromethorphan HBr / Cough Suppressant
Guaifenesin / Expectorant
Phenylephrine HCl / Nasal Decongestant

• Controls cough
• Relieves nasal & chest congestion
• Thins & loosens mucus

20
COATED
CAPLETS

Compare to Maximum Strength Mucinex® FAST-MAX®
Severe Congestion & Cough active ingredients‡‡

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

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

ǂWalgreens Pharmacist Survey Study, November 2014.
ǂǂThis product is not manufactured or distributed by Reckitt
Benckiser LLC, owner of the registered trademark
Maximum Strength Mucinex® FAST-MAX® Severe
Congestion & Cough.

50844 REV0214A64809 ORG0415-F_R01

Walgreens 44-648

MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH
dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-6480
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 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 BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED (maroon)	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	44;648
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-6480-09	2 in 1 CARTON	07/20/2015	10/18/2020
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	07/20/2015	10/18/2020

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(0363-6480)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(0363-6480)

Revised: 9/2018

Document Id: 736c91e3-620b-4e73-8b5f-27e27014561d

Set id: 04500362-a5ca-487a-8198-dcfcbc5aad19

Version: 5

Effective Time: 20180904

Walgreen Company