SUDAFED PE SINUS CONGESTION- diphenhydramine hydrochloride and phenylephrine hydrochloride kit

SUDAFED PE SINUS CONGESTION by

Drug Labeling and Warnings

SUDAFED PE SINUS CONGESTION by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SUDAFED PE® DAYTIME

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

• temporarily relieves sinus congestion and pressure
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

When using this product do not exceed recommended dose

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or occur with a fever

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. (1-800-222-1222)

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

• store between 20-25°C (68-77°F)
• do not use if blister unit is torn or broken

Inactive ingredients

carnauba wax, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide

Questions or comments?

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

SUDAFED PE® NIGHTTIME

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)	Purpose
Diphenhydramine HCl 25 mg	Antihistamine
Phenylephrine HCl 10 mg	Nasal decongestant

Uses

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

Warnings

Do not use

• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin
• 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.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

• do not exceed recommended dose
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or occur with a fever

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. (1-800-222-1222)

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

• store between 20-25°C (68-77°F)
• do not use if blister unit is torn or broken

Inactive ingredients

carnauba wax, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide

Questions or comments?

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

PREVIOUSLY SUDAFED PE® DAY + NIGHT SINUS CONGESTION
NDC: 50580-239-01

SUDAFED PE®

SINUS CONGESTION

Phenylephrine HCl
Nasal Decongestant

DAYTIME

• NASAL
  CONGESTION

actual size

12 TABLETS 10 mg each

Diphenhydramine HCl, Phenylephrine HCl
Antihistamine, Nasal Decongestant

NIGHTTIME

• NASAL CONGESTION
• RUNNY NOSE

actual size

8 TABLETS | TOTAL: 20 TABLETS

INGREDIENTS AND APPEARANCE

SUDAFED PE SINUS CONGESTION 
diphenhydramine hydrochloride and phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-239

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-239-01	1 in 1 PACKAGE	06/17/2019

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

Part 1 of 2

SUDAFED PE SIINUS CONGESTION 
phenylephrine hydrochloride 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
carnauba wax (UNII: R12CBM0EIZ)
D&C yellow no. 10 (UNII: 35SW5USQ3G)
FD&C red no. 40 (UNII: WZB9127XOA)
FD&C yellow no. 6 (UNII: H77VEI93A8)
aluminum oxide (UNII: LMI26O6933)
magnesium stearate (UNII: 70097M6I30)
microcrystalline cellulose (UNII: OP1R32D61U)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
polyvinyl alcohol, unspecified (UNII: 532B59J990)
powdered cellulose (UNII: SMD1X3XO9M)
sodium starch glycolate Type A potato (UNII: 5856J3G2A2)
talc (UNII: 7SEV7J4R1U)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	WL;80;PE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 CARTON
1		6 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	06/17/2019

Part 2 of 2

SUDAFED PE SINUS CONGESTION PLUS ALLERGY 
diphenhydramine hydrochloride and phenylephrine hydrochloride 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
carnauba wax (UNII: R12CBM0EIZ)
FD&C blue no. 1--aluminum lake (UNII: J9EQA3S2JM)
magnesium stearate (UNII: 70097M6I30)
microcrystalline cellulose (UNII: OP1R32D61U)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
polyvinyl alcohol, unspecified (UNII: 532B59J990)
powdered cellulose (UNII: SMD1X3XO9M)
sodium starch glycolate Type A potato (UNII: 5856J3G2A2)
talc (UNII: 7SEV7J4R1U)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	PE;WL95
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 CARTON
1		4 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	06/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/17/2019

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)