TOPCARE TUSSIN CF MAX- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

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:

Topco Associates LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Authorization status:

OTC monograph final

Summary of Product characteristics

TOPCARE TUSSIN CF MAX- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,
GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE SOLUTION
TOPCO ASSOCIATES 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._
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TOPCO ASSOCIATES LLC. TUSSIN CF MAX DRUG FACTS
ACTIVE INGREDIENTS (IN EACH 20 ML)
Acetaminophen, USP 650 mg
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 400 mg
Phenylephrine HCl, USP 10 mg
PURPOSES
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
USES
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WARNINGS
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if
you take
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temporarily relieves these symptoms occurring with a cold or flu:
cough due to minor throat and bronchial irritation
nasal congestion
sinus congestion and pressure
minor aches and pains
sore throat
headache
temporarily reduces fever
helps loosen phlegm (mucus) and thin bronchial secretions to drain
bronchial tubes
and make coughs more productive
more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
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ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms
may
include:
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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
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ASK A DOCTOR BEFORE USE IF YOU HAVE
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ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking the blood thinning drug warfarin
WHEN USING THIS PRODUCT DO NOT USE MORE THAN DIRECTED
STOP USE AND ASK A DOCTOR IF
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3 or more alcoholic drinks every day while using this product
skin reddening
blisters
rash
if you are now taking a prescription monoamine oxidase inhibitor
(MAOI) (certain
drugs for depr