ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE- acetaminophen, diphenhydramine hydrochloride, and phe

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:

AAA Pharmaceutical, Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves these symptoms of hay fever and the common cold: runny nose sneezing headache minor aches and pains nasal congestion sore throat - runny nose - sneezing - headache - minor aches and pains - nasal congestion - sore throat - temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes - itching of the nose or throat - itchy, watery eyes - temporarily reduces fever

Authorization status:

OTC monograph final

Summary of Product characteristics

ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE
HYDROCHLORIDE- ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND
PHENYLEPHRINE
HYDROCHLORIDE TABLET, COATED
AAA PHARMACEUTICAL, 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._
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ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL -1156
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
_PURPOSE_
Acetaminophen 325 mg
Pain reliever/fever
reducer
Diphenhydramine HCl 25 mg
Antihistamine
Phenylephrine HCl 5 mg
Nasal decongestant
US ES
temporarily relieves these symptoms of hay fever and the common cold:
runny nose
sneezing
headache
minor aches and pains
nasal congestion
sore throat
temporarily relieves these additional symptoms of hay fever:
itching of the nose or throat
itchy, watery eyes
temporarily reduces fever
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
you take
more than 12 caplets 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
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.
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.
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease
heart dise