WAL-PHED PE, MULTI-SYMPTOM- acetaminophen, diphenhydramine hcl and phenylephrine hcl tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Walgreen Company

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant - temporarily relieves these symptoms due to the common cold: runny nose sneezing headache minor aches and pains nasal congestion cough sore throat - runny nose - sneezing - headache - minor aches and pains - nasal congestion - cough - sore throat - temporarily reduces fever  - temporarily relieves sinus congestion and pressure 

Authorization status:

OTC monograph final

Summary of Product characteristics

WAL-PHED PE, MULTI-SYMPTOM- ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND
PHENYLEPHRINE HCL TABLET, FILM COATED
WALGREEN COMPANY
_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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WALGREENS 44-526
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
_PURPOSE_
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant
_USES_
temporarily relieves these symptoms due to the common cold:
runny nose
sneezing
headache
minor aches and pains
nasal congestion
cough
sore throat
temporarily reduces fever
temporarily relieves sinus congestion and pressure
_WARNINGS_
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur
if you take:
more than 4,000 mg 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 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 a 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.
with any other product containing diphenhydramine, even one used on
skin
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 reactio