SEVERE COLD PE- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

TopCare

INN (Международно Name):

ACETAMINOPHEN

Композиция:

ACETAMINOPHEN 325 mg

Начин на приложение:

ORAL

Вид предписание :

OTC DRUG

Терапевтични показания:

- temporarily relieves these symptoms of the common cold: runny nose sneezing headache sore throat minor aches and pains nasal congestion cough - runny nose - sneezing - headache - sore throat - minor aches and pains - nasal congestion - cough - temporarily reduces fever

Статус Оторизация:

OTC monograph final

Данни за продукта

SEVERE COLD PE- ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND
PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED
TOPCARE
_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._
----------
1124 - TCR - 2018-1228
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH_
_CAPLET)_
_PURPOSE_
Acetaminophen 325 mg
Pain reliever/fever
reducer
Diphenhydramine HCl 12.5 mg
Antihistamine/cough
suppressant
Phenylephrine HCl 5 mg
Nasal decongestant
USES
temporarily relieves these symptoms of the common cold:
runny nose
sneezing
headache
sore throat
minor aches and pains
nasal congestion
cough
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
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
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 reaction to this product or any of
its ingredients
AS