COLD AND FLU- acetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Spirit Pharmaceuticals LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves common cold/flu symptoms: - nasal congestion - sinus congestion & pressure - cough due to minor throat & bronchial irritation - minor aches & 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.

Authorization status:

OTC monograph final

Summary of Product characteristics

COLD AND FLU- ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN
HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED
SPIRIT PHARMACEUTICALS 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._
----------
MAXIMUM STRENGTH COLD & FLU
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH_
_SOFTGEL)_
_PURPOSE_
Acetaminophen 325 mg
Pain reliever/fever reducer
Dextromethorphan HBr 10 mg
Cough suppressant
Guaifenesin 200 mg
Expectorant
Phenylephrine HCl 5 mg
Nasal decongestant
USES
temporarily relieves common cold/flu symptoms:
nasal congestion
sinus congestion & pressure
cough due to minor throat & bronchial irritation
minor aches & 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.
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
you take
more than 12 softgels in 24 hours, which is the maximum daily amount
for this
product
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 emo