CHILDRENS DELSYM COUGH PLUS COLD NIGHT TIME- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solut

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 nasal congestion minor aches and pains sore throat headache runny nose sneezing - cough - nasal congestion - minor aches and pains - sore throat - headache - runny nose - sneezing - temporarily reduces fever - controls cough to help your child get to sleep

Authorization status:

OTC monograph final

Summary of Product characteristics

CHILDRENS DELSYM COUGH PLUS COLD NIGHT TIME- ACETAMINOPHEN,
DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE
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._
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CHILDREN'S DELSYM
COUGH PLUS COLD NIGHT TIME
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH 10_
_ML)_
_PURPOSES_
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 common cold and flu symptoms:
cough
nasal congestion
minor aches and pains
sore throat
headache
runny nose
sneezing
temporarily reduces fever
controls cough to help your child get to sleep
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
your child
takes:
more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
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.
to make a child sleepy
with any other product containing diphenhydramine, even one used on
the skin
in a child who is 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 child's
prescription drug contains an MAOI, ask a doctor or pharmacist before
giving this
produc