COLD AND FLU SEVERE DAYTIME NIGHTTIME- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, guaifenesin, and

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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:

MEIJER

Prescription type:

OTC DRUG

Therapeutic indications:

- for the temporary relief of the following cold/flu symptoms: minor aches and pain headache sore throat nasal congestion cough - minor aches and pain - headache - sore throat - nasal congestion - cough - helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive - temporarily reduces fever - for the temporary relief of the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure sneezing and runny nose - minor aches and pains - headache - sore throat - nasal congestion - cough - sinus congestion and pressure - sneezing and runny nose - helps clear nasal passages - relieves cough to help you sleep - temporarily reduces fever

Authorization status:

OTC monograph final

Summary of Product characteristics

COLD AND FLU SEVERE DAYTIME NIGHTTIME- ACETAMINOPHEN, CHLORPHENIRAMINE
MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE
HYDROCHLORIDE
MEIJER
_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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MEI-1186-2019-0521
COLD + FLU SEVERE DAY
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
_PURPOSE_
Acetaminophen 325 mg
Pain reliever/fever
reducer
Dextromethorphan HBr 10 mg
Cough suppressant
Guaifenesin 200 mg
Expectorant
Phenylephrine HCl 5 mg
Nasal decongestant
US ES
for the temporary relief of the following cold/flu symptoms:
minor aches and pain
headache
sore throat
nasal congestion
cough
helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more productive
temporarily reduces fever
WARNINGS
LIVER WARNING
This product contains acetaminophen. The maximum daily dose of this
product is 10 caplets (3,250 mg
acetaminophen) in 24 hours. Severe liver damage may occur if you take
more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
ALLERGY ALERT
Acetaminophen may cause severe skin reactions. Symptoms may include:
skin reddening
blisters
rash
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
with any other drug containing acetaminophen (prescription or
nonprescription). If you are not sure
whether a drug contains acetaminophen, ask a doctor or pharmacist.
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