Extra Strength Tylenol® Severe Cough + Sore Throat Night
f81d924e-10e9-0e9d-e053-6294a90a2ddf
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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 |
|
| 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 |
|
| 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
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:21.758642 · Updated: 2026-03-14T23:05:02.267888