MUCUS RELIEF, COLD, FLU AND SORE THROAT MAXIMUM STRENGTH, MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, guaifenesin, pheny

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:

Salado Sales, Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant - temporarily relieves these common cold and flu symptoms: minor aches and pains nasal congestion cough headache sore throat - minor aches and pains - nasal congestion - cough - headache - sore throat - helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive  - temporarily reduces fever

Authorization status:

OTC monograph final

Summary of Product characteristics

MUCUS RELIEF, COLD, FLU AND SORE THROAT MAXIMUM STRENGTH, MULTI-
SYMPTOM- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN,
PHENYLEPHRINE HCL TABLET, FILM COATED
SALADO SALES, 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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CVP 44-616
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
_PURPOSE_
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
_USES_
temporarily relieves these common cold and flu symptoms:
minor aches and pains
nasal congestion
cough
headache
sore throat
helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial
passageways of bothersome mucus and make coughs more productive
temporarily reduces fever
_WARNINGS_
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if
you take
with other drugs containing acetaminophen
more than 4,000 mg of acetaminophen in 24 hours
3 or more alcoholic drinks every day while using this product
ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms
may
include:
blisters
rash
skin reddening
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
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
with any other drug containing acetaminophen (prescription or
nonprescription).