NIGHTTIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Wal-Mart Stores Inc

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant - temporarily relieves common cold and flu symptoms: minor aches and pains sinus congestion and pressure sore throat fever headache nasal congestion cough due to minor throat and bronchial irritation runny nose and sneezing - minor aches and pains - sinus congestion and pressure - sore throat - fever - headache - nasal congestion - cough due to minor throat and bronchial irritation - runny nose and sneezing - reduces swelling of nasal passages - promotes nasal and/or sinus drainage - temporarily restores freer breathing through the nose

Authorization status:

OTC monograph final

Summary of Product characteristics

NIGHTTIME SEVERE COLD AND FLU- ACETAMINOPHEN, DEXTROMETHORPHAN HBR,
DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL TABLET, FILM COATED
WAL-MART STORES 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._
----------
EQUATE 44-677
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
_PURPOSE_
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
_USES_
temporarily relieves common cold and flu symptoms:
minor aches and pains
sinus congestion and pressure
sore throat
fever
headache
nasal congestion
cough due to minor throat and bronchial irritation
runny nose and sneezing
reduces swelling of nasal passages
promotes nasal and/or sinus drainage
temporarily restores freer breathing through the nose
_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:
blisters
rash
skin reddening
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 stopping the MAOI drug. If you do not know if your
prescription
drug contains an MAOI, ask a docto