Extra Strength Tylenol® Severe Cough + Sore Throat Night

Extra Strength Tylenol® Severe Cough + Sore Throat Night
SPL v4
SPL
SPL Set ID f81d924e-10e9-0e9d-e053-6294a90a2ddf
Route
ORAL
Published
Effective Date 2024-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (1000 mg) Dextromethorphan (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Form Polyethylene Glycol, Unspecified Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-19

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

temporarily relieves these common cold/flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • cough
  • sneezing and runny nose

temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Section 55105-1
Active ingredients (in each 30 mL) Purpose
Acetaminophen 1,000 mg Pain reliever/fever reducer
Dextromethorphan HBr 30 mg Cough suppressant
Doxylamine Succinate 12.5 mg Antihistamine
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
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
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
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.

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
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.

Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, 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)

Principal Display Panel

NDC 50580-243-01

EXTRA STRENGTH TYLENOL ®

FOR ADULTS

SEVERE COUGH + SORE THROAT

NEW!

DOSAGE + DIRECTIONS

Acetaminophen,

Dextromethorphan HBr, Doxylamine Succinate

Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine

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

NIGHT

FROSTED BERRY

8 fl oz (240 mL)

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

Ask A Doctor Before Use If You Have
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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
  • taking sedatives or tranquilizers

Structured Label Content

Uses

temporarily relieves these common cold/flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • cough
  • sneezing and runny nose

temporarily reduces fever

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each 30 mL) Purpose
Acetaminophen 1,000 mg Pain reliever/fever reducer
Dextromethorphan HBr 30 mg Cough suppressant
Doxylamine Succinate 12.5 mg Antihistamine
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
Do Not Use (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
Liver Warning (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
Overdose Warning (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.

Other Information (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
Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, 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? (Questions or comments?)

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-243-01

EXTRA STRENGTH TYLENOL ®

FOR ADULTS

SEVERE COUGH + SORE THROAT

NEW!

DOSAGE + DIRECTIONS

Acetaminophen,

Dextromethorphan HBr, Doxylamine Succinate

Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine

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

NIGHT

FROSTED BERRY

8 fl oz (240 mL)

When Using This Product (When using this product)
  • do not exceed recommended dose
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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 (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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