THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride p

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:

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 500 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant

Authorization status:

OTC monograph final

Summary of Product characteristics

THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER-
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE
HYDROCHLORIDE POWDER
GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (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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DRUG FACTS
_ACTIVE INGREDIENTS (IN EACH PACKET)_
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
_PURPOSES_
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant
_USES_
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_WARNINGS_
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur
if you take
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temporarily relieves these symptoms due to a cold
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minor aches and pains
minor sore throat pain
headache
nasal and sinus congestion
runny nose
sneezing
itchy nose or throat
itchy, watery eyes due to hay fever
cough due to minor throat and bronchial irritation
temporarily reduces fever
more than 4,000 mg of acetaminophen in 24 hours
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ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms
may
include:
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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
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ASK A DOCTOR BEFORE USE IF YOU HAVE
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ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
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WHEN USING THIS PRODUCT
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with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
skin reddening
blisters
rash
If a skin reaction occurs, stop use and seek medical help right away.
in a child under 12 years of age
if you are allergic to acetaminophen
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 pro