ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE- acetaminophen, dextromethorphan hydrobro

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:

AAA Pharmaceutical, Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- for the temporary relief of the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough impulse to cough - minor aches and pains - headache - sore throat - nasal congestion - cough - impulse to cough - helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive - temporarily reduces fever

Authorization status:

OTC monograph final

Summary of Product characteristics

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN,
PHENYLEPHRINE HYDROCHLORIDE- ACETAMINOPHEN, DEXTROMETHORPHAN
HYDROBROMIDE,
GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED
AAA PHARMACEUTICAL, INC.
_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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ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL
TABLETS
_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 pains
headache
sore throat
nasal congestion
cough
impulse to cough
helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more productive
temporarily reduces fever
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
you take
more than 12 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
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.
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease
heart disease
high blood press