LEADER DAY TIME 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)

Available from:

Cardinal Health

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg in 15 mL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

                                LEADER DAY TIME- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN,
PHENYLEPHRINE
HCL SOLUTION
CARDINAL HEALTH
_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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CARDINAL HEALTH DAY TIME 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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nasal congestion
sinus congestion and pressure
cough due to minor throat and bronchial irritation
minor aches and pains
headache
fever
sore throat
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 doses (30 mL each) in 24 hours which is the
maximum daily amount for this
product
child takes more than 4 doses (15 mL each) in 24 hours which is the
maximum daily amount for
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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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this product
taken with other drug
                                
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