SANATOS- acetaminophen, dextromethorphan hbr, phenylephrine hci, doxylamine succinate capsule, liquid filled

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), 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:

Daytime Relief Temporarily relieves common cold/flu symptoms: - headache - minor aches and pains - sore throat - nasal and sinus congestion - stuffy nose Temporarily reduces fever Nighttime Relief Temporarily relieves common cold/flu symptoms: - cough due to minor throat and bronchial irritation - headache - minor aches and pains - sneezing - sore throat - runny nose - itchy nose or throat - itchy, watery eyes due to hay fever - Temporarily reduces fever

Authorization status:

OTC monograph final

Summary of Product characteristics

SANATOS- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI,
DOXYLAMINE
SUCCINATE CAPSULE, LIQUID FILLED
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 MULTI-SYMPTONS DAY & NIGHT 24 GELCAPS DUAL PACK
_DRUG FACTS_
_ACTIVE INGREDIENTS_
DAYTIME RELIEF
ACTIVE INGREDIENTS (IN EACH LIQUICAP)
PURPOS ES
Acetaminophen 325 mg.......
Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg..............
Cough suppressant
Phenylephrine HCI 5 mg.......................
Nasal decongestant
NIGHTTIME RELIEF
Active ingredients (in each liquicap)
Purposes
Acetaminophen 325 mg........
Pain reliever/ fever reducer
Dextromethorphan HBr 15 mg...............
Cough suppressant
Doxylamine succinate 6.25 mg........................
Antihistamine
_USE_
DAYTIME RELIEF
Temporarily relieves common cold/u symptoms:
headache
minor aches and pains
sore throat
nasal and sinus congestion
stuffy nose Temporarily reduces fever
NIGHTTIME RELIEF
Temporarily relieves common cold/u symptoms:
cough due to minor throat and bronchial irritation
headache
minor aches and pains
sneezing
sore throat
runny nose
itchy nose or throat
itchy, watery eyes due to hay fever
Temporarily reduces fever
_WARNINGS_
LIVER WARNING:
DAYTIME & NIGHTTIME
This product contains acetaminophen.
Severe liver damage may occur if you take
more than 4 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
ALLERGY ALERT: ACETAMINOPHEN
DAYTIME & NIGHTTIME
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:
DAYTIME & NIGHTTIME
If sore throat is severe, persists for
more than 2 days, is accompanied, or followed by fever,
headache, rash, nausea, or vomiting, consult a doct