MAXIMUM STRENGTH ALLERGY SINUS- acetaminophen, chlorpheniramine maleate, pseudoephedrine 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 44-342-Delisted

Active ingredients (in each caplet)

Acetaminophen 500 mg
Chlorpheniramine maleate 2 mg
Pseudoephedrine HCl 30 mg

Purpose

Pain reliever
Antihistamine
Nasal decongestant

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- nasal congestion
- sinus pain
- headache
- sinus pressure
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat

Warnings

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

more than 8 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

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 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 whether your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if

glaucoma
liver disease
heart disease
thyroid disease
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
high blood pressure
diabetes

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 occurs, especially in children
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

nervousness, dizziness, or sleeplessness occur
pain or nasal congestion gets worse or lasts more than 7 days
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present

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. 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 take more than directed
(see overdose warning)
adults and children 12 years and over: 2 caplets every 4 to 6 hours. Do not take more than 8 caplets in 24 hours.
children under 12 years: do not use this 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 controlled room temperature 15º-30ºC (59º-86ºF)
protect from moisture
see end flap for expiration date and lot number
for better identification keep caplets in carton until used

Inactive ingredients

carnauba wax, cellulose, crospovidone, D&C yellow#10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica gel, sodium starch glycolate, starch, stearic acid, titanium dioxide, triacetin

Questions or comments?

1-800-426-9391

Principal display panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0342-08

MAXIMUM STRENGTH
Allergy
Sinus-D
D Allergy & Sinus
Acetaminophen 500 mg / Pain Reliever
Pseudoephedrine HCl 30 mg / Nasal Decongestant
Chlorpheniramine Maleate 2 mg / Antihistamine
• Relief of runny nose, sneezing, nasal congestion,
sinus pain/pressure & itchy, watery eyes

24 CAPLETS

ǂWalgreens Pharmacist Survey Study, November 2010.

50844 ORG101115712 ITEM 510072 ORG1112-F
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

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

Walgreens 44-342

MAXIMUM STRENGTH ALLERGY SINUS
acetaminophen, chlorpheniramine maleate, pseudoephedrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-3420
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSPOVIDONE (UNII: 68401960MK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	44;342
Contains

#	Item Code	Package Description
Packaging
1	NDC:0363-3420-08	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	10/01/1999	06/10/2018

Labeler - WALGREEN CO. (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(0363-3420)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(0363-3420)

Revised: 6/2015

Document Id: 8ea5f196-8c1b-43ba-98c0-b23e18ee3ebc

Set id: 0a4ace8c-562e-43af-9efb-d323ee4c22ab

Version: 3

Effective Time: 20150610

WALGREEN CO.