FDA Label for Extra Strength Tylenol Severe Cough Plus Sore Throat Night
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- LIVER WARNING
- SORE THROAT WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Extra Strength Tylenol Severe Cough Plus Sore Throat Night Product Label
The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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.
Otc - Purpose
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 |
Uses
temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- cough
- sneezing and runny nose
temporarily reduces fever
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
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)
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
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.
- 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
adults and children 12 years and over | |
children under 12 years | ask a doctor |
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 50580-243-01
EXTRA STRENGTH TYLENOL ®
FOR ADULTS
SEVERE COUGH + SORE THROAT
NEW!
DOSAGE + DIRECTIONS
Acetaminophen,
1,000 mg / 30 mL
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)
* Please review the disclaimer below.