SANATOS X- acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hci liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pharmadel LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves these common cold/ flu symptoms: - minor aches and pains - headache - sore throat - cough due to minor throat and bronchial irritation - helps loosen phlegm (mucus) and thin bronchial - secretions to drain bronchial tubes - make coughs more productive - nasal congestion - stuffy nose - hay fever - temporarily reduces fever

Authorization status:

OTC monograph final

Summary of Product characteristics

SANATOS X- ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN,
PHENYLEPHRINE HCI LIQUID
PHARMADEL LLC
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SANATOS X FAST ACTION (PLE)(APTA)
DRUG FACTS
ACTIVE INGREDIENTS AND PURPOSES
ACTIVE INGREDIENTS (IN EACH 20 ML)
PURPOSES
ACETAMINOPHEN 650MG ......
PAIN RELIEVER/FEVER REDUCER
Dextromethorphan HBr 20 mg .............
Cough suppressant
Guaifenesin 400 mg .....................................
Expectorant
Phenylephrine HCI 10 mg...................
Nasal decongestant
USES
temporarily relieves these common cold/ flu symptoms:
minor aches and pains
headache
sore throat
cough due to minor throat and bronchial irritation
helps loosen phlegm (mucus) and thin bronchial
secretions to drain bronchial tubes
make coughs more productive
nasal congestion
stuffy nose
hay fever
temporarily reduces fever
WARNINGS
LIVER WARNING:
This product contains ACETAMINOPHEN.
Severe liver damage may occur if you:
take more than 6 doses in 24 hours, which is the maximum daily amount
take with other drugs containing acetaminophen
have 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 an allergic reaction occurs, stop use and seek medical help
right away.
SORE THROAT WARNING:
Severe or persistent sore throat or sore throat accompanied by high
fever, headache,
nausea, and vomiting may be serious. Consult physician 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 or your child 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
child’s or your prescription drug contains an MAOI, ask a doctor or
pharmacist
before taking this product.
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking the bl