Extra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime
- Dosage form
- LIQUID
- Labeler
- Kenvue Brands LLC
- Label updated
- 2026-05-21
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN · DEXTROMETHORPHAN HYDROBROMIDE · DOXYLAMINE SUCCINATE
Label information
Drug Facts
성분·작용
|
Active ingredients (in each 30 mL) |
Purpose |
| Acetaminophen 1000 mg | Pain reliever/fever reducer |
|
Dextromethorphan HBr 30 mg |
Cough suppressant |
| Doxylamine succinate 12.5 mg | Antihistamine |
Uses
■ temporarily relieves these common cold/flu symptoms
■ minor aches and pains
■ headache
■ sore throat
■ cough
■ sneezing and runny nose
■ temporarily reduces fever
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
Label information
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
■ 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)
Label information
Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
Label information
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.
Label information
If pregnant or breast-feeding, ask a health professional before use.
Label information
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 |
|
|
children under 12 years |
|
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 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 50580-212-01
Extra Strength
TYLENOL
®
FOR ADULTS
COLD + FLU
MULTI-SYMPTOM
Acetaminophen,Dextromethorphan HBr, Doxylamine Succinate
Pain Reliever-Fever Reducer, Cough Suppressant, Antihistamine
NIGHT
• HEAD + BODY ACHES
• FEVER • SORE THROAT
• COUGH • SNEEZING
• RUNNY NOSE
FROSTED BERRY
8 fl oz
(240 mL)
[Image in the official label — see DailyMed source]
DailyMed Set ID: 525467fb-510d-0b4b-e063-6294a90acd36 · Version 1
NDC: 50580-212