WAL-PHED PE NON-DRYING SINUS- guaifenesin, phenylephrine hcl tablet
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 44-548 Delisted

Active ingredients (in each caplet)

Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Expectorant
Nasal decongestant

Uses

temporarily relieves nasal congestion
promotes nasal and/or sinus drainage
temporarily relieves sinus congestion and pressure
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 accompanied by too much phlegm (mucus)

When using this product

do not exceed recommended dose

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
cough gets worse or lasts more than 7 days
symptoms do not improve within 7 days, or occur with a fever
cough tends to come back or occurs with fever, rash, or headache that lasts. These couldb e signs of oa 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 right away.

Directions

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

store at controlled room temperature 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

NDC 0363-0548-08

Compare to Sudafed PE® Non-Drying Sinus active ingredients*

Walgreens

WAL-PHED® PE
Guaifenesin 200 mg, Phenylephrine HCl 5 mg
Expectorant, Nasal Decongestant
NON-DRYING SINUS

Relieves:
• Sinus Pressure
• Sinus Drainage
• Nasal & Sinus Congestion

24 COATED CAPLETS

12 DOSES, 2 Pills Per Dose
PSEUDOEPHEDRINE FREE

*This product is not manufactured or distributed byMcNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Non-Drying Sinus.
50844 REV0510B54808

Distributed by: Walgreen Co.,
200 Wilmot Rod., Deerfield, IL 60015-4616

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

Walgreens 44-548

WAL-PHED PE NON-DRYING SINUS
guaifenesin, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0548
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	44;548
Contains

#	Item Code	Package Description
Packaging
1	NDC:0363-0548-08	2 in 1 CARTON
1		12 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	09/17/2003	09/22/2018

Labeler - WALGREEN CO. (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(0363-0548)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(0363-0548)

Revised: 9/2015

Document Id: d34fd132-53d8-4737-b6aa-5455ad0da830

Set id: 870ceabe-cd66-49b7-b002-8fffc03f09b1

Version: 3

Effective Time: 20150922

WALGREEN CO.