TYLENOL COLD MAX NIGHT- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride sol

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D), Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS), Doxylamine Succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL), Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)

Available from:

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion runny nose and sneezing cough sinus congestion and pressure helps clear nasal passages relieves cough to help you sleep temporarily reduces fever - minor aches and pains - headache - sore throat - nasal congestion - runny nose and sneezing - cough - sinus congestion and pressure - helps clear nasal passages - relieves cough to help you sleep - temporarily reduces fever

Authorization status:

OTC monograph final

Summary of Product characteristics

TYLENOL COLD MAX NIGHT- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,
DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE SOLUTION
JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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TYLENOL COLD MAX
NIGHT
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH 15 ML)_
_PURPOSE_
Acetaminophen 325 mg
Pain reliever/fever
reducer
Dextromethorphan HBr 10 mg
Cough suppressant
Doxylamine succinate 6.25 mg
Antihistamine
Phenylephrine HCl 5 mg
Nasal decongestant
US ES
temporarily relieves these common cold/flu symptoms:
minor aches and pains
headache
sore throat
nasal congestion
runny nose and sneezing
cough
sinus congestion and pressure
helps clear nasal passages
relieves cough to help you sleep
temporarily reduces fever
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