ALLERGY AND SINUS HEADACHE- acetaminophen, diphenhydramine hcl and phenylephrine hcl tablet, film coated

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:

ARMY AND AIR FORCE EXCHANGE SERVICE

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever Antihistamine Nasal decongestant - temporarily relieves these symptoms of hay fever and the common cold: runny nose sneezing headache minor aches and pains nasal congestion - runny nose - sneezing - headache - minor aches and pains - nasal congestion - temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes - itching of the nose or throat - itchy, watery eyes

Authorization status:

OTC monograph final

Summary of Product characteristics

ALLERGY AND SINUS HEADACHE- ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND
PHENYLEPHRINE HCL TABLET, FILM COATED
ARMY AND AIR FORCE EXCHANGE SERVICE
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EXCHANGE SELECT 44-464
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
_PURPOSE_
Pain reliever
Antihistamine
Nasal decongestant
_USES_
temporarily relieves these symptoms of hay fever and the common cold:
runny nose
sneezing
headache
minor aches and pains
nasal congestion
temporarily relieves these additional symptoms of hay fever:
itching of the nose or throat
itchy, watery eyes
_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
3 or more alcoholic drinks every day while using this product
with other drugs containing acetaminophen
ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms
may
include:
blisters
rash
skin reddening
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
glaucoma
thyroid disease
heart disease
diabetes
high blood pressure
difficulty in urination due to enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking the blood thinning drug warfarin
taking sedatives