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TYLENOL Cold Multi-Symptom Daytime (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Archived
  3. Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Generic: acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride

TYLENOL Cold Multi-Symptom Daytime tablet, film coated - (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg phenylephrine hydrochloride 5 mg) image

IMPRINT: TYLENOL 1078     SHAPE: oval
    COLOR: white

  1. FDA Adverse Reactions

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Drug Facts

Otc - Active Ingredient Section


OTC - PURPOSE SECTION

Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant

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

Warnings


Liver warning


This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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.

OTC - DO NOT USE SECTION


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

OTC - ASK DOCTOR SECTION


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)

OTC - ASK DOCTOR/PHARMACIST SECTION


Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION


When using this product do not exceed recommended dose

OTC - STOP USE SECTION


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 lastsThese could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION


If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole; do not crush, chew or dissolve
  • do not take more than 10 caplets in 24 hours
children under 12 years ask a doctor

Other Information

  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or if buler unit is broken

Inactive Ingredients


anhydrous citric acid, carnauba wax, corn starch, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, potassium sorbate, powdered

cellulose, pregelatinized starch, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose

Questions Or Comments?


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

Principal Display Panel


NDC 50580-406-24

See New Warnings Information & Directions

TYLENOL ® COLDMULTI-SYMPTOMFor Adults

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBrPain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant

DAYTIMENon-Drowsy

Headache, Fever, Sore ThroatNasal CongestionCough

24 CAPLETS

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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