Extra Strength TYLENOL Cold Plus Flu Multi-Action Day ACETAMINOPHEN PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE KENVUE BRANDS LLC FDA Approved Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure helps clear nasal passages promotes nasal and sinus drainage 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 caplet) Purpose Acetaminophen 500 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant Pseudoephedrine HCl 30 mg Nasal decongestant
Inactive Ingredients
Inactive ingredients carnauba wax hypromellose magnesium stearate microcrystalline cellulose powdered cellulose pregelatinized starch propylene glycol sodium starch glycolate titanium dioxide
Strengths
500 mg 15 mg 30 mg
Treats Conditions
Uses Temporarily Relieves These Common Cold Flu Symptoms Minor Aches And Pains Headache Sore Throat Nasal Congestion Cough Sinus Congestion And Pressure Helps Clear Nasal Passages Promotes Nasal And Sinus Drainage Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: white Imprint: TY;COLD;1408

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0300450147240
UNII
362O9ITL9D 9D2RTI9KYH 6V9V2RYJ8N
Packaging

PRINCIPAL DISPLAY PANEL NDC 50580-344-01 Extra Strength TYLENOL ® FOR ADULTS COLD + FLU MULTI-ACTION Acetaminophen, Dextromethorphan HBr, Pseudoephedrine HCl Pain Reliever-Fever Reducer, Cough Suppressant, Nasal Decongestant DAY NON-DROWSY HEAD + BODY ACHES FEVER + SORE THROAT COUGH NASAL CONGESTION Actual Size 24 CAPLETS tylenol-01

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 50580-344-01 Extra Strength TYLENOL ® FOR ADULTS COLD + FLU MULTI-ACTION Acetaminophen, Dextromethorphan HBr, Pseudoephedrine HCl Pain Reliever-Fever Reducer, Cough Suppressant, Nasal Decongestant DAY NON-DROWSY HEAD + BODY ACHES FEVER + SORE THROAT COUGH NASAL CONGESTION Actual Size 24 CAPLETS tylenol-01

Overview

Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure helps clear nasal passages promotes nasal and sinus drainage temporarily reduces fever

Indications & Usage

Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure helps clear nasal passages promotes nasal and sinus drainage temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets 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 heart disease high blood pressure thyroid disease diabetes 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 When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion 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, 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

Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant Pseudoephedrine HCl 30 mg Nasal decongestant

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 nervousness, dizziness, or sleeplessness occur pain, nasal congestion 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 store between 20 - 25°C (68 - 77°F). do not use if blister unit is torn or broken

Questions

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


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