DAYTIME COLD AND FLU NON DROWSY- acetaminohpen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
27-03-2023

ingredients actius:

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

Disponible des:

P & L Development, LLC

Vía de administración:

ORAL

tipo de receta:

OTC DRUG

indicaciones terapéuticas:

Pain reliever/fever reducer Cough suppressant Nasal decongestant - temporarily relieves common cold and flu symptoms: minor aches and pains headache sore throat nasal congestion fever cough due to minor throat and bronchial irritation - minor aches and pains - headache - sore throat - nasal congestion - fever - cough due to minor throat and bronchial irritation

Estat d'Autorització:

OTC monograph final

Fitxa tècnica

                                DAYTIME COLD AND FLU NON DROWSY- ACETAMINOHPEN, DEXTROMETHORPHAN
HBR, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED
P & L DEVELOPMENT, 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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DRUG FACTS
ACTIVE INGREDIENTS (IN EACH SOFTGEL)
ACETAMINOPHEN 325 MG
Dextromethoprhan HBr 10 mg
Phenlyephrine HCL 5 mg
PURPOSE
PAIN RELIEVER/FEVER REDUCER
Cough suppressant
Nasal decongestant
USES
temporarily relieves common cold and flu symptoms:
minor aches and pains
headache
sore throat
nasal congestion
fever
cough due to minor throat and bronchial irritation
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.
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 pharmacist before taking this
product.
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease
diabetes
heart disease
thyroid disease
high blood pressure
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs 
                                
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