SUDAFED PE PRESSURE PLUS PAIN PLUS COUGH DAY- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride solution

Sudafed PE Pressure Plus Pain Plus Cough by

Drug Labeling and Warnings

Sudafed PE Pressure Plus Pain Plus Cough by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 15 mL)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporarily relieves these common cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • cough
  • sinus congestion and pressure
• helps clear nasal passages
• promotes nasal and sinus drainage
• temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma or emphysema
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dose

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see overdose warning)
• mL = milliliter
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

• adults and children 12 years and over:
  • take 30 mL in the dosing cup provided every 4 hours while symptoms last
  • do not take more than 150 mL in 24 hours, unless directed by a doctor
• children under 12 years: ask a doctor

Other information

• each 15 mL contains: sodium 5 mg
• store between 20-25°C (68-77°F). Do not refrigerate.
• do not use if neck band imprinted with "SUDAFED PE" or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Inactive ingredients

alcohol, anhydrous citric acid, FD&C yellow no. 6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

SINUS
NDC: 50580-362-01

SUDAFEDPE®

PRESSURE+PAIN +COUGH
For
Adults

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Pain Reliever–Fever Reducer, Cough Suppressant, Nasal Decongestant

DAY™

SINUS PRESSURE
SINUS CONGESTION
SINUS HEADACHE
SORE THROAT
COUGH

Alcohol 0.5%

NON-DROWSY

8 fl oz (240 mL)

INGREDIENTS AND APPEARANCE

SUDAFED PE PRESSURE PLUS PAIN PLUS COUGH  DAY
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-362
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D)	acetaminophen	325 mg  in 15 mL
dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	dextromethorphan hydrobromide	10 mg  in 15 mL
phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV)	phenylephrine hydrochloride	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
alcohol (UNII: 3K9958V90M)
anhydrous citric acid (UNII: XF417D3PSL)
FD&C yellow no. 6 (UNII: H77VEI93A8)
glycerin (UNII: PDC6A3C0OX)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	CITRUS	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-362-01	240 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	06/25/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/25/2018

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