Extra Strength TYLENOL Severe Cough Plus Sore Throat Day ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE KENVUE BRANDS LLC FDA Approved Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat cough temporarily reduces fever
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients(in each 30 mL) Acetaminophen 1 000 mg Dextromethorphan HBr 30 mg
Inactive Ingredients
Inactive ingredients anhydrous citric acid carboxymethylcellulose sodium FD&C red no 40 flavors glycerin microcrystalline cellulose and carboxymethylcellulose sodium poloxamer polyethylene glycol propylene glycol purified water sodium benzoate sorbitol sucralose
Strengths
30 ml 1000 mg 30 mg
Quantities
240 ml
Treats Conditions
Uses Temporarily Relieves These Common Cold Flu Symptoms Minor Aches And Pains Headache Sore Throat Cough Temporarily Reduces Fever
Pill Appearance
Color: red

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0300450565082
UNII
362O9ITL9D 9D2RTI9KYH
Packaging

PRINICIPAL DISPLAY PANEL NEW NDC 50580-140-08 EXTRA STRENGHT TYLENOL ® FOR ADULTS SEVERE COUGH + SORE THROAT Acetaminophen, Dextromethorphan HBr, Pain Reliever-Fever Reducer, Cough Suppressant HEAD+BODY ACHES FEVER+ SORE THROAT COUGH DAY COOLING CHERRY 8 fl oz (240 mL) tylenol.jpg

Package Descriptions
  • PRINICIPAL DISPLAY PANEL NEW NDC 50580-140-08 EXTRA STRENGHT TYLENOL ® FOR ADULTS SEVERE COUGH + SORE THROAT Acetaminophen, Dextromethorphan HBr, Pain Reliever-Fever Reducer, Cough Suppressant HEAD+BODY ACHES FEVER+ SORE THROAT COUGH DAY COOLING CHERRY 8 fl oz (240 mL) tylenol.jpg

Overview

Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat cough temporarily reduces fever

Indications & Usage

Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat cough temporarily reduces fever

Dosage & Administration

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 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 children under 12 years ask a doctor

Warnings & Precautions
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 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 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 When using this product do not exceed recommended dose 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. If pregnant or breast-feeding, If pregnant or breast-feeding, ask a health professional before use. 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.
Purpose

Purpose Pain reliever/fever reducer Cough suppressant

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

When Using

When using this product do not exceed recommended dose

Stop Use & Ask a Doctor

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.

Keep Out of Reach of Children

Keep out of reach of children.

Storage & Handling

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

Questions

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


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