SINUS CONGESTION AND PAIN DAYTIME- acetaminophen and phenylephrine hcl tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Wal-Mart Stores Inc

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

SINUS CONGESTION AND PAIN DAYTIME- ACETAMINOPHEN AND PHENYLEPHRINE
HCL TABLET
WAL-MART STORES 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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EQUATE 44-558-DELISTED
_ACTIVE INGREDIENTS (IN EACH GELCAP)_
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
_PURPOSE_
Pain reliever/fever reducer
Nasal decongestant
_USES_
temporarily relieves these symptoms associated with hay fever or other
respiratory
allergies, and the common cold:
headache
nasal congestion
sinus congestion and pressure
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. 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.
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
heart disease
diabetes
liver disease
thyroid disease
difficulty in urination due to enlargement of the prostate gland
high blood pressure
ASK A DOCTOR OR PHARMACIST BEFORE USE IF Y