EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY- acetaminophen and dextromethorphan hydrobromide liquid

Extra Strength TYLENOL Severe Cough Plus Sore Throat Day by

Drug Labeling and Warnings

Extra Strength TYLENOL Severe Cough Plus Sore Throat Day by is a Otc medication manufactured, distributed, or labeled by Kenvue Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients(in each 30 mL)

Acetaminophen 1,000 mg

Dextromethorphan HBr 30 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Uses

• temporarily relieves these common cold/flu symptoms:
• minor aches and pains
• headache
• sore throat
• cough
• 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
• 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

• pain 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,

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)
• shake well before using
• 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 6 hours while symptoms last
  • do not take more than 90 mL in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
• children under 12 years: ask a doctor

Other information

• each 30 mL contains: sodium 19 mg
• store between 20-25°C (68-77°F)
• do not use if neck band imprinted with “INSTANT COOLING SENSATION” or foil inner seal imprinted with

“TYLENOL” is broken or missing

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, FD&C red no 40, flavors, glycerin,microcrystalline cellulose and carboxymethylcellulose sodium,poloxamer, polyethylene glycol,propylene glycol, purified water,sodium benzoate, sorbitol, sucralose

Questions or comments?

call 1-877-895-3665 (toll-free) or

215-273-8755 (collect)

PRINICIPAL DISPLAY PANEL

NEW

NDC: 50580-140-08

EXTRA STRENGHT TYLENOL ®

FOR ADULTS

SEVERE COUGH + SORE THROAT

Acetaminophen,

Dextromethorphan HBr, Pain Reliever-Fever Reducer, Cough Suppressant

• HEAD+BODY ACHES
• FEVER+ SORE THROAT
• COUGH

DAY

COOLING CHERRY

8 fl oz (240 mL)

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY 
acetaminophen and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-140
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	1000 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-140-08	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/06/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/06/2025

Labeler - Kenvue Brands LLC (118772437)