ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE- acetaminophen and phenylephrine hydrochloride tablet, coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Commercializzato da:

AAA Pharmaceutical, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

OTC DRUG

Indicazioni terapeutiche:

- temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: headache sinus congestion and pressure nasal congestion minor aches and pains - headache - sinus congestion and pressure - nasal congestion - minor aches and pains - helps decongest sinus openings and passages - promotes sinus drainage - helps clear nasal passages - temporarily reduces fever

Stato dell'autorizzazione:

OTC monograph final

Scheda tecnica

ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE- ACETAMINOPHEN AND
PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED
AAA PHARMACEUTICAL, INC.
_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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RES - 1123 - 2019-1012
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN_
_EACH CAPLET)_
_PURPOSE_
Acetaminophen 325 mg
Pain reliever/fever
reducer
Phenylephrine HCl 5 mg
Nasal decongestant
USES
temporarily relieves these symptoms associated with hay fever or other
upper
respiratory allergies, and the common cold:
headache
sinus congestion and pressure
nasal congestion
minor aches and pains
helps decongest sinus openings and passages
promotes sinus drainage
helps clear nasal passages
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
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
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking the blood
thinning drug
warfarin
WHEN USIN