SPL v8
SPL
SPL Set ID 47c61858-72ce-409b-a3af-a63620cf7d13
Route
ORAL
Published
Effective Date 2018-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg) Doxylamine (325 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Glycerin Propylene Glycol Water Sodium Benzoate Sorbitol Solution Sucralose Alcohol

Identifiers & Packaging

Pill Appearance
Color: brown Color: yellow Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-10-03

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily relieves the following cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever
Section 42229-5

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.

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not exceed recommended dose

Section 50568-5

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

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 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
Section 55106-9

Active ingredients (in each 30 mL) Purpose

Acetaminophen 650 mg Pain reliever/fever reducer

Dextromethorphan HBr 20 mg Cough suppressant

Guaifenesin 400 mg Expectorant

Phenylephrine HCl 10 mg Nasal decongestant

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
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.

Tylenol Cold Max

Drug Facts

Other Information
  • each 30 mL contains : sodium 10 mg
  • store between 20-25°C (68-77°F).
  • do not use if neck band imprinted with " WARMING 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, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions Or Comments?

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

Principal Display Panel

NDC 50580-241-01

DAYTIME

TYLENOL ®

FOR ADULTS

COLD + FLU SEVERE

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin



Pain Reliever–Fever Reducer, Cough Suppressant, Nasal Decongestant, Expectorant

  • HEAD + BODY ACHES
  • FEVER + SORE THROAT
  • COUGH
  • NASAL CONGESTION
  • MUCUS + CHEST CONGESTION

Warming



HONEY



LEMON

8 fl oz (240 mL)

NIGHTTIME

TYLENOL ®

FOR ADULTS

COLD MAX

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl



Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine, Nasal Decongestant

  • HEAD + BODY ACHES
  • FEVER + SORE THROAT
  • COUGH
  • NASAL CONGESTION
  • RUNNY NOSE

COOL



BURST
®

Alcohol 0.5%

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
Tylenol Cold + Flu Severe

Drug Facts

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.

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, chronic bronchitis, 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 the following cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever
Section 42229-5 (42229-5)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose

Section 50568-5 (50568-5)

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

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 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
Section 55106-9 (55106-9)

Active ingredients (in each 30 mL) Purpose

Acetaminophen 650 mg Pain reliever/fever reducer

Dextromethorphan HBr 20 mg Cough suppressant

Guaifenesin 400 mg Expectorant

Phenylephrine HCl 10 mg Nasal decongestant

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
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.

Tylenol Cold Max (TYLENOL COLD MAX)

Drug Facts

Other Information (Other information)
  • each 30 mL contains : sodium 10 mg
  • store between 20-25°C (68-77°F).
  • do not use if neck band imprinted with " WARMING 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, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, 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 50580-241-01

DAYTIME

TYLENOL ®

FOR ADULTS

COLD + FLU SEVERE

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin



Pain Reliever–Fever Reducer, Cough Suppressant, Nasal Decongestant, Expectorant

  • HEAD + BODY ACHES
  • FEVER + SORE THROAT
  • COUGH
  • NASAL CONGESTION
  • MUCUS + CHEST CONGESTION

Warming



HONEY



LEMON

8 fl oz (240 mL)

NIGHTTIME

TYLENOL ®

FOR ADULTS

COLD MAX

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl



Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine, Nasal Decongestant

  • HEAD + BODY ACHES
  • FEVER + SORE THROAT
  • COUGH
  • NASAL CONGESTION
  • RUNNY NOSE

COOL



BURST
®

Alcohol 0.5%

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
Tylenol Cold + Flu Severe

Drug Facts

Stop Use and Ask A Doctor If (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.

Ask A Doctor Before Use If You Have (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, chronic bronchitis, 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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