SEVERE COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Walgreen Company

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg in 15 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant temporarily relieves common cold/flu symptoms:

Authorization status:

OTC monograph final

Summary of Product characteristics

                                SEVERE COLD AND FLU- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN,
PHENYLEPHRINE HCL SOLUTION
WALGREEN COMPANY
_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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WALGREEN CO. SEVERE COLD & FLU DRUG FACTS
ACTIVE INGREDIENTS (IN EACH 15 ML)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
PURPOSE
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
USES
temporarily relieves common cold/flu symptoms:
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WARNINGS
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if
sinus congestion and pressure
nasal congestion
minor aches and pains
headache
sore throat
fever
cough due to minor throat and bronchial irritation
reduces swelling of nasal passages
promotes nasal and/or sinus drainage
temporarily restores freer breathing through the nose
helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial
passageways of bothersome mucus and make coughs more productive
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ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms
may
include:
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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
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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
taking the blood thinning drug warfarin
WHEN USING THIS PRODUCT
DO NOT USE MORE THAN DIRECTED
STOP USE AND ASK A DOCTOR IF
adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this
product
skin red
                                
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