ALLERGY PLUS SINUS RELIEF- diphenhydramine hcl and phenylephrine hcl tablet, film coated

Allergy Plus Sinus Relief by

Drug Labeling and Warnings

Allergy Plus Sinus Relief by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each tablet)

Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg 

Purpose

Antihistamine
Nasal decongestant 

Uses

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

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.
• with any other product containing diphenhydramine, even one used on skin 

Ask a doctor before use if you have

• heart disease
• diabetes
• high blood pressure
• difficulty in urination due to enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• thyroid disease

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• do not exceed recommended dosage
• excitability may occur, especially in children
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic beverages
• use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• symptoms do not improve within 7 days or are accompanied by fever
• nervousness, dizziness, or sleeplessness occur

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

• do not take more than directed
  
• adults and children 12 years and over
  
  • take 1 tablet every 4 hours
    
  • do not take more than 6 tablets in 24 hours
    
• children under 12 years: do not use
  

Other information

• each tablet contains: calcium 25 mg
  
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin

Questions or comments?

1-800-426-9391

Principal display panel

Compare to the active ingredients in
Benadryl® Allergy Plus Congestion*

ALLERGY PLUS
SINUS RELIEF
PHENYLEPHRINE HCl
DIPHENHYDRAMINE HCl

ANTIHISTAMINE
NASAL DECONGESTANT
RELIEF OF
Sneezing, runny nose, sinus congestion,
sinus pressure, itchy throat,
& itchy, watery eyes

24 
TABLETS

*This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark Benadryl® Allergy Plus Congestion.
50844        ORG122048508

DISTRIBUTED BY:
RITE AID, 200 NEWBERRY COMMONS,
ETTERS, PA 17319 www.riteaid.com

SATISFACTION GUARANETT: If you're not
satisfied, we'll happily refund your money.

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

Rite Aid 44-485

INGREDIENTS AND APPEARANCE

ALLERGY PLUS SINUS RELIEF 
diphenhydramine hcl and phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0485
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	44;485
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0485-8	2 in 1 CARTON	08/10/2005
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/10/2005

Labeler - Rite Aid Corporation (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(11822-0485) , pack(11822-0485)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	manufacture(11822-0485)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		117025878	manufacture(11822-0485)