DELSYM COUGH PLUS COLD NIGHT TIME- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for sol

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:

RB Health (US) LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves these common cold and flu symptoms: cough minor aches and pains headache sore throat nasal congestion runny nose sneezing - cough - minor aches and pains - headache - sore throat - nasal congestion - runny nose - sneezing - temporarily reduces fever - controls cough to help you get to sleep

Authorization status:

OTC monograph final

Summary of Product characteristics

DELSYM COUGH PLUS COLD NIGHT TIME- ACETAMINOPHEN, DIPHENHYDRAMINE
HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR SOLUTION
RB HEALTH (US) LLC
_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._
----------
DELSYM
COUGH PLUS™ COLD NIGHT TIME
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN_
_EACH PACKET)_
_PURPOSES_
ACETAMINOPHEN 650 MG
PAIN RELIEVER/FEVER
REDUCER
Diphenhydramine HCl 25 mg
Antihistamine/cough
suppressant
Phenylephrine HCl 10 mg
Nasal decongestant
USES
temporarily relieves these common cold and flu symptoms:
cough
minor aches and pains
headache
sore throat
nasal congestion
runny nose
sneezing
temporarily reduces fever
controls cough to help you get to sleep
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
you take:
more than 6 packets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks daily 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 drug containing diphenhydramine, even one used on the
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 disease
diabetes
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
glaucoma
breathi