COLD FLU SEVERE- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Dostupné z:

STRATEGIC SOURCING SERVICES LLC

Spôsob podávania:

ORAL

Typ predpisu:

OTC DRUG

Terapeutické indikácie:

- for the temporary relief of the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough - minor aches and pains - headache - sore throat - nasal congestion - cough - helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive - temporarily reduces fever

Stav Autorizácia:

OTC monograph final

Súhrn charakteristických

COLD FLU SEVERE- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,
GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED
STRATEGIC SOURCING SERVICES 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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SMK - 1163 - 2020-0603
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH_
_CAPLET)_
_PURPOSE_
Acetaminophen 325 mg
Pain reliever/fever
reducer
Dextromethorphan HBr 10 mg
Cough suppressant
Guaifenesin 200 mg
Expectorant
Phenylephrine HCl 5 mg
Nasal decongestant
USES
for the temporary relief of the following cold/flu symptoms:
minor aches and pains
headache
sore throat
nasal congestion
cough
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.
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.
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