SANATOS NIGHTTIME MULTI SYMPTOMS- acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

Pharmadel LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

temporarily relieves these common cold/flu symptoms: - sore throat - headache - minor aches and pains - fever - runny nose and sneezing - cough due to minor throat and bronchial irritation

Authorization status:

OTC monograph final

Summary of Product characteristics

SANATOS NIGHTTIME MULTI SYMPTOMS- ACETAMINOPHEN, DEXTROMETHORPHAN HBR,
DOXYLAMINE SUCCINATE 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® NIGHTTIME MULTI SYMPTOMS
_DRUG FACTS_
_ACTIVE INGREDIENTS & PURPOSES_
_ACTIVE INGREDIENTS_ (in each 30 mL dose cup)
_PURPOSES_
Acetaminophen 650 mg
Pain reliever/fever reducer
Dextromethorphan HBr 30 mg
Cough suppressant
Doxylamine succinate 12 mg
Antihistamine
_USES_
temporarily relieves these common cold/flu symptoms:
sore throat
headache
minor aches and pains
fever
runny nose and sneezing
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 everyday 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
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.
to make a child sleepy
_ASK A DOCTOR B