SINUS CONGESTION AND PAIN SEVERE- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, 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:

TopCare

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: sinus congestion and pressure headache nasal congestion minor aches and pains - sinus congestion and pressure - headache - nasal congestion - minor aches and pains - 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

SINUS CONGESTION AND PAIN SEVERE- ACETAMINOPHEN, GUAIFENESIN, AND
PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED
TOPCARE
_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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1119 - TCR - 2018-1228
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
_PURPOSE_
Acetaminophen 325 mg
Pain reliever/fever
reducer
Guaifenesin 200 mg
Expectorant
Phenylephrine HCl 5 mg
Nasal decongestant
USES
temporarily relieves these symptoms associated with hay fever or other
upper
respiratory allergies, and the common cold:
sinus congestion and pressure
headache
nasal congestion
minor aches and pains
helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more
productive
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
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
liver disease
heart disease
hig