Daytime and Nighttime Sinus Congestion PE: Package Insert and Label Information

DAYTIME AND NIGHTTIME SINUS CONGESTION PE- diphenhydramine hcl, phenylephrine hcl
CVS Pharmacy

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.

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

CVS Health_™

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

DAYTIME — Non-Drowsy NIGHTTIME

Sinus Sinus
Congestion PE Congestion PE

PHENYLEPHRINE HCI DIPHENHYDRAMINE HCl
Nasal decongestant Antihistamine

Relieves: PHENYLEPHRINE HCl
Nasal congestion Nasal decongestant

Actual Size Relieves:
12 TABLETS 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 CVSV-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

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 Multilevel Packaging 1 NDC:69842-938-09 1 KIT in 1 PACKAGE, COMBINATION None

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM DEXTROSE MONOHYDRATE DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C RED NO. 40 LECITHIN, SOYBEAN MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM TRISODIUM CITRATE DIHYDRATE TITANIUM DIOXIDE

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

Packaging # Item Code Package Description Multilevel Packaging 1 12 TABLET, FILM COATED in 1 BLISTER PACK None

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN

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

Packaging # Item Code Package Description Multilevel Packaging 1 8 TABLET, FILM COATED in 1 BLISTER PACK None

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	Operations
LNK International, Inc.		832867894	MANUFACTURE (69842-938)

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

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

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

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

Revised: 06/2020 CVS Pharmacy