Drug Facts
TYLENOL® Cold + Flu Multi-Symptom Liquid Gels Day
TYLENOL® Cold + Flu Multi-Symptom Liquid Gels Night
Tylenol Cold Plus Flu Multi-symptom Liquid Gels Day Plus Night Kit
FDA Label NDC 50580-141
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Tylenol Cold Plus Flu Multi-symptom Liquid Gels Day Plus Night (NDC 50580-141). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - active ingredient, otc - purpose, uses, warnings, liver warning, allergy alert, sore throat warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each capsule)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Otc - Purpose
Pain reliever/fever reducer
Cough suppressant
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains
■ headache
■ sore throat
■ cough
■ temporarily reduces fever
■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains
■ headache
■ sore throat
■ cough
■ runny nose and sneezing
■ temporarily reduces fever
Warnings
Warnings
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
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.
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
■ 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)
■ 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)
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers
Otc - When Using
When using this product do not exceed recommended dose
■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
Otc - Stop Use
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.
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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.
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)
| adults and children 12 years and over | ■ take 2 capsules every 4 hours while symptoms last
■ do not take more than 8 capsules in 24 hours |
| Children 4 to under 12 years | ask a doctor |
| Children under 4 years | do not use |
■ do not take more than directed (see overdose warning)
| adults and children 12 years and over | ■ take 2 capsules every 6 hours while symptoms last
■ do not take more than 8 capsules in 24 hours |
| Children 4 to under 12 years | ask a doctor |
| Children under 4 years | do not use |
Other Information
■ store at 20° to 25°C (68° to 77°F)
■ avoid high humidity and excessive heat above 40°C (104°F)
■ protect from light
■
do not use if blister unit is torn or broken
■ store at 20° to 25°C (68° to 77°F)
■ avoid high humidity and excessive heat above 40°C (104°F)
■ protect from light
■ do not use if blister unit is torn or broken
Inactive Ingredients
FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin,lecithin, mineral oil, polyethylene glycol, povidone, propylene glycol, purified water,sorbitol sorbitan solution
D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin,lecithin, mineral oil, polyethylene glycol, povidone, propylene glycol, purified water,sorbitol sorbitan solution
Questions Or Comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Active Ingredient (In Each Capsule)
Active ingredient (in each capsule)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
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.
Principal Display Panel
NDC 50580-141-03
TYLENOL ®
FOR ADULTS
COLD & FLU
MULTI SYMPTOM
LIQUID GELS
Acetaminophen,
Dextromethorphan HBr
Pain Reliever–Fever Reducer,
Cough Suppressant
DAY
• HEAD + BODY ACHES
• FEVER + SORE THROAT
• COUGH
Actual Size
3X16 LIQUID GELS
Acetaminophen,
Dextromethorphan HBr, Doxylamine Succinate
Pain Reliever-Fever Reducer,
Cough Suppressant, Antihistamine
NIGHT
• HEAD + BODY ACHES
• FEVER + SORE THROAT
• COUGH • RUNNY NOSE
Actual Size
3X8 LIQUID GELS
TOTAL 72 LIQUID GELS*
*LIQUID FILLED CAPSULES
Tylenol-1.jpg (Tylenol 1)
* Please review the disclaimer below.
