DAYTIME AND NIGHTTIME SINUS CONGESTION PE- diphenhydramine hcl, phenylephrine hcl kit

Daytime and Nighttime Sinus Congestion by

Drug Labeling and Warnings

Daytime and Nighttime Sinus Congestion by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, 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

CVSHealth™

Compare to the active ingredients in
Sudafed PE® Day + Night Sinus Congestion*

DAYTIME - Non-Drowsy                                       

Sinus
Congestion PE

PHENYLEPHRINE HCI
Nasal decongestant

Relieves:
Nasal congestion

Actual Size
12 TABLETS

NIGHTTIME

Sinus
Congestion PE

DIPHENHYDRAMINE HCI
Antihistamine
PHENYLEPHRINE HCI
Nasal decongestant

Relieves:
Nasal congestion
Runny nose

Actual Size
8 TABLETS

 20 TOTAL TABLETS

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

50844      REV0118A45348509

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-19849

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

CVS 44-453485

INGREDIENTS AND APPEARANCE

DAYTIME AND NIGHTTIME SINUS CONGESTION  PE
diphenhydramine hcl, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-938

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-938-09	1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	06/10/2019

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 CONGESTION  PE
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	01/14/2005

Part 2 of 2

NIGHTTIME SINUS CONGESTION  PE
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	08/10/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/10/2019

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(69842-938)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(69842-938)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(69842-938)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(69842-938)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(69842-938)