SINUS PRESSURE AND CONGESTION RELIEF- diphenhydramine hcl, phenylephrine hcl kit

Sinus Pressure and Congestion Relief by

Drug Labeling and Warnings

Sinus Pressure and Congestion 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 ingredient (in each tablet) (Sinus Day)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Active ingredients (in each tablet) (Sinus Night)

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
  • sneezing (Nighttime only)
    
  • runny nose (Nighttime only)
    
  • itchy, watery eyes (Nighttime only)
  • itching of the nose or throat (Nighttime only)
    
• temporarily relieves these symptoms due to the common cold:
  
  • nasal congestion
  • sneezing (Nighttime only)
    
  • runny nose (Nighttime only)
• 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 (Nighttime only)
  

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers. (Nighttime only)

When using this product

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

Stop use and ask a doctor if

• symptoms do not improve within 7 days or occur with 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 (1-800-222-1222) right away.

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.

Directions

• 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: ask a doctor
  

Other information

• each tablet contains: calcium 25 mg (Nighttime only)
  
• 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 (Daytime only)

croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Inactive ingredients (Nighttime only)

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 Sudafed PE® Day + Night Sinus Congestion*

SINUS PRESSURE & CONGESTION RELIEF PE

DAYTIME

PHENYLEPHRINE HCl
NASAL DECONGESTANT
NON-DROWSY

Relieves nasal
congestion

ACTUAL SIZE

NIGHTTIME

DIPHENHYDRAMINE HCl
PHENYLEPHRINE HCl
ANTIHISTAMINE,
NASAL DECONGESTANT

Relieves nasal
congestion
runny nose

ACTUAL SIZE

12 DAYTIME
TABLETS

8 NIGHTTIME
TABLETS

RITE
AID®
PHARMACY

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

DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com

SATISFACTION GUARANTEE
if you're not satisfied, we'll
happily refund your money.

*The product is not manufactured or distributed by
Johnson & Johnson, owner of  the registered trademark
Sudafed PE® Day + Night Sinus Congestion.

50844   REV0118A45348509

Rite Aid 44-453485

INGREDIENTS AND APPEARANCE

SINUS PRESSURE AND CONGESTION RELIEF 
diphenhydramine hcl, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-9485

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-9485-9	1 in 1 CARTON; Type 0: Not a Combination Product	07/02/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	12
Part 2	1 BLISTER PACK	8

Part 1 of 2

DAYTIME SINUS PRESSURE AND CONGESTION RELIEF 
phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;453
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 FINAL	part341	07/02/2019

Part 2 of 2

NIGHTTIME SINUS PRESSURE AND CONGESTION RELIEF 
diphenhydramine hcl, phenylephrine hcl tablet, film coated

Product Information
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		8 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 FINAL	part341	07/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/02/2019

Labeler - Rite Aid Corporation (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(11822-9485)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(11822-9485)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(11822-9485)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(11822-9485)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(11822-9485)