DAYTIME SEVERE- 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:

Shopko Stores Operating Co., LLC

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: taking the blood thinning drug warfarin

Authorization status:

OTC monograph final

Summary of Product characteristics

                                DAYTIME SEVERE- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN,
PHENYLEPHRINE
HCL SOLUTION
SHOPKO STORES OPERATING CO., 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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SHOPKO DAYTIME SEVERE DRUG FACTS
ACTIVE INGREDIENTS (IN EACH 15 ML)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
PURPOS E
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
US ES
temporarily relieves common cold/flu symptoms:
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WARNINGS
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if
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sore throat
nasal congestion
sinus congestion and pressure
cough due to minor throat and bronchial irritation
minor aches and pains
fever
headache
reduces swelling of nasal passages
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial passageways of
bothersome mucus and make coughs more productive
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
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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
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adult has 3 or more alcoholic drinks every day while using thi
                                
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