SEVERE ALLERGY RELIEF PLUS SINUS HEADACHE- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet,

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:

GoodSense

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose sneezing headache minor aches and pains nasal congestion sinus congestion and pressure itchy, watery eyes itching of the nose or throat - runny nose - sneezing - headache - minor aches and pains - nasal congestion - sinus congestion and pressure - itchy, watery eyes - itching of the nose or throat

Authorization status:

OTC monograph final

Summary of Product characteristics

SEVERE ALLERGY RELIEF PLUS SINUS HEADACHE- ACETAMINOPHEN,
DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE TABLET,
COATED
GOODSENSE
_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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GDS - 1126 - 2016-0523
_DRUG FACTS_
_ACTIVE INGREDIENTS _
_(IN EACH CAPLET)_
_PURPOSE_
Acetaminophen 325 mg
Pain reliever
Diphenhydramine HCl 25 mg
Antihistamine
Phenylephrine HCl 5 mg
Nasal decongestant
USES
temporarily relieves these symptoms of hay fever or other upper
respiratory
allergies:
runny nose
sneezing
headache
minor aches and pains
nasal congestion
sinus congestion and pressure
itchy, watery eyes
itching of the nose or throat
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.
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
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma