SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME- acetaminophen, guaifenesin and phenylephrine hcl tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Valu Merchandisers Company

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Expectorant Nasal decongestant - temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: minor aches and pains nasal congestion sinus congestion and pressure headache - minor aches and pains - nasal congestion - sinus congestion and pressure - headache - helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive - temporarily reduces fever

Authorization status:

OTC monograph final

Summary of Product characteristics

SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME-
ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL TABLET, FILM COATED
VALU MERCHANDISERS COMPANY
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BEST CHOICE 44-527C DELISTED
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
_PURPOSE_
Pain reliever/fever reducer
Expectorant
Nasal decongestant
_USES_
temporarily relieves these symptoms associated with hay fever or other
respiratory
allergies, and the common cold:
minor aches and pains
nasal congestion
sinus congestion and pressure
headache
helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more
productive
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:
blisters
rash
skin reddening
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
liver disease
thyroid disease
diabetes
heart disease
high blood pressure
persistent or chronic cough such as occurs with smoking, asthma,
chronic
bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)
difficulty in urination due to enlargement of the prostate gland
ASK A DOCTOR OR PHARMA