DAYTIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

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Prenos Lastnosti izdelka (SPC)
06-12-2023

Aktivna sestavina:

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)

Dostopno od:

Spirit Pharmaceuticals LLC

Pot uporabe:

ORAL

Tip zastaranja:

OTC DRUG

Terapevtske indikacije:

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant • for the temporary relief of the following cold/flu symptoms: • minor aches and pains • headache • sore throat • nasal congestion • cough • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • temporarily reduces fever • 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 MAOI, ask a doctor or pharmacist before taking this product. • if you have ever had an allergic reaction to this product or any of its ingredients. • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough that occurs with too much phlegm (mucus) if you are taking the blood thinning drug warfarin • nervousness, dizziness, or sleeplessness occur • pain, nasal congestion or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Status dovoljenje:

OTC monograph final

Lastnosti izdelka

                                DAYTIME SEVERE COLD AND FLU- ACETAMINOPHEN, DEXTROMETHORPHAN
HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE TABLET,
FILM
COATED
SPIRIT PHARMACEUTICALS LLC
----------
DAYTIME SEVERE COLD AND FLU
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5
_PURPOSE_
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
_USES_
• for the temporary relief of the following cold/flu symptoms: •
minor aches and pains
• 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
MAOI, ask a doctor
or pharmacist before taking this product. • if you have ever had an
allergic reaction to
this product or any of its ingredients
                                
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