MUCINEX FAST-MAX NIGHT TIME COLD AND FLU- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet,

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:

RB Health (US) LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves these common cold and flu symptoms: - cough - minor aches and pains - headache - nasal congestion - sore throat - sinus congestion and pressure - runny nose - sneezing - itching of the nose or throat - itchy, watery eyes due to hay fever - controls cough to help you get to sleep - temporarily reduces fever

Authorization status:

OTC monograph final

Summary of Product characteristics

MUCINEX FAST-MAX NIGHT TIME COLD AND FLU- ACETAMINOPHEN,
DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE TABLET,
FILM
COATED
RB HEALTH (US) LLC
_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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MUCINEX® FAST-MAX
NIGHT TIME COLD & FLU
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH_
_CAPLET)_
_PURPOSES_
ACETAMINOPHEN 325 MG
PAIN RELIEVER/FEVER REDUCER
Diphenhydramine HCl 12.5 mg
Antihistamine/cough
suppressant
Phenylephrine HCl 5 mg
Nasal decongestant
USES
temporarily relieves these common cold and flu symptoms:
cough
minor aches and pains
headache
nasal congestion
sore throat
sinus congestion and pressure
runny nose
sneezing
itching of the nose or throat
itchy, watery eyes due to hay fever
controls cough to help you get to sleep
temporarily reduces fever
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
you take:
more than 12 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product
ALLERGY ALERT
®
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.
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