SEVERE COLD AND COUGH RELIEF NIGHTTIME- acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid

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:

H E B

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 650 mg in 30 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Antihistamine / Cough suppressant Nasal decongestant - temporarily relieves these symptoms due to a cold minor aches and pains sore throat headache runny nose sneezing itchy,watery eyes due to hay fever nasal and sinus congestion itchy of the nose or throat  cough due to minor throat and bronchial irritation - minor aches and pains - sore throat - headache - runny nose - sneezing - itchy,watery eyes due to hay fever - nasal and sinus congestion - itchy of the nose or throat  - cough due to minor throat and bronchial irritation - temporarily reduces fever

Authorization status:

OTC monograph final

Summary of Product characteristics

SEVERE COLD AND COUGH RELIEF NIGHTTIME- ACETAMINOPHEN,
DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL LIQUID
H E B
_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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DRUG FACTS
ACTIVE INGREDIENTS (IN EACH 30 ML)
ACETAMINOPHEN 650 MG
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
PURPOSES
PAIN RELIEVER/FEVER REDUCER
Antihistamine /
Cough suppressant
Nasal decongestant
USES
temporarily relieves these symptoms due to a cold
minor aches and pains
sore throat
headache
runny nose
sneezing
itchy,watery eyes due to hay fever
nasal and sinus congestion
itchy of the nose or throat
cough due to minor throat and bronchial irritation
temporarily reduces fever
WARNINGS
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur
if you take :
more than 4,000 mg of acetaminophen in 24 hours
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
to make a child sleepy
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.
with any other product containing diphenhydramine, even one used on
skin
with any other drug containing acetaminophen (prescription or
non-prescription). If
you are not sure whether a drug contains acetaminophen, ask a doctor
or
pharmacist.
ASK A