SANATOS MULTI SYMPTOM DAYTIME- acetaminophen, dextromethorphan hbr, phenylephrine hci liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pharmadel LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Active ingredients (in each 15 mL, 1 tablespoon) temporarily relieves common cold/flu symptoms: - minor aches & pains - headache - sore throat - fever - nasal congestion - cough due to minor throat and bronchial irritation

Authorization status:

OTC monograph final

Summary of Product characteristics

SANATOS MULTI SYMPTOM DAYTIME- ACETAMINOPHEN, DEXTROMETHORPHAN HBR,
PHENYLEPHRINE HCI LIQUID
PHARMADEL 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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SANATOS® DAYTIME MULTI-SYMPTOMS
_DRUG FACTS_
_ACTIVE INGREDIENTS & PURPOSES_
_ACTIVE INGREDIENTS_
_(in each 15 mL, 1 tablespoon)_
_PURPOSES_
ACETAMINOPHEN 325 MG
PAIN RELIEVER/FEVER REDUCER
Dextromethorphan HBr 10 mg
Cough suppressant
Phenylephrine HCI 5 mg
Nasal decongestant
_USES_
temporarily relieves common cold/flu symptoms:
minor aches & pains
headache
sore throat
fever
nasal congestion
cough due to minor throat and bronchial irritation
_WARNINGS_
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if
adults take more than 4,000 mg if acetaminophen in 24 hours
child take more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 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
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.
with any other drug containing acetaminophen (prescription or
nonprescription). If you are not sure
whether a drug contains acetaminophen, ask a doctor or pharmacist.
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease
heart disease
thyroid disease
diabetes
h