THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Haleon US Holdings LLC

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant - temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation - minor aches and pains - minor sore throat pain - headache - nasal and sinus congestion - runny nose - sneezing - itchy nose or throat - itchy, watery eyes due to hay fever - cough due to minor throat and bronchial irritation - temporarily reduces fever

Authorization status:

OTC monograph final

Summary of Product characteristics

THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH-
ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL TABLET, FILM
COATED
HALEON US HOLDINGS LLC
----------
DRUG FACTS
_ACTIVE INGREDIENT_
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
_PURPOSE_
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant
_USES_
temporarily relieves these symptoms due to a cold:
minor aches and pains
minor sore throat pain
headache
nasal and sinus congestion
runny nose
sneezing
itchy nose or throat
itchy, watery eyes due to hay fever
cough due to minor throat and bronchial irritation
temporarily reduces fever
_WARNINGS_
LIVER WARNING:This product contains acetaminophen. Severe lever 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
in a child under 12 years of age
if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or
nonprescription). If
you are not sure whether a drug contains acetaminophen, ask a doctor
or
pharmacist.
with any other product containing diphenhydramine, even one used on
the skin
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.
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
trouble urina