NIGHT TIME MULTI SYMPTOM FLU COLD MEDICINE- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Buy It Now

Active ingredient:

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

Available from:

Salado Sales, Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Cough suppressant Antihistamine - temporarily relieves common cold and flu symptoms: sore throat fever minor aches and pains headache runny nose and sneezing cough due to minor throat and bronchial irritation  - sore throat - fever - minor aches and pains - headache - runny nose and sneezing - cough due to minor throat and bronchial irritation 

Authorization status:

OTC monograph final

Summary of Product characteristics

                                NIGHT TIME MULTI SYMPTOM FLU COLD MEDICINE- ACETAMINOPHEN,
DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED
SALADO SALES, INC.
_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._
----------
CVP 44-660
_ACTIVE INGREDIENTS (IN EACH LIQUID-FILLED CAPSULE)_
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
_PURPOSE_
Pain reliever/fever reducer
Cough suppressant
Antihistamine
_USES_
temporarily relieves common cold and flu symptoms:
sore throat
fever
minor aches and pains
headache
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 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.
if you have ever had an allergic reaction to this product or any of
its ingredients
to make a child sleepy
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
glaucoma
                                
                                Read the complete document