American Sales Company Cold + Flu Severe Drug Facts

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:

American Sales Company

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg

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

CAREONE COLD PLUS FLU SEVERE- ACETAMINOPHEN, DEXTROMETHORPHAN HBR,
GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM COATED
AMERICAN SALES COMPANY
_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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AMERICAN SALES COMPANY COLD + FLU SEVERE DRUG FACTS
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
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WARNINGS
Liver warning: This product contains acetaminophen. Severe liver
damage may occur if
you take
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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
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:
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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 exceed recommended dosage
STOP USE AND ASK A DOCTOR IF
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skin reddening
blisters
rash
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