SEVERE COLD DM- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride powder, for 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), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Walgreen Company

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Authorization status:

OTC monograph final

Summary of Product characteristics

SEVERE COLD DM- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,
PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR SOLUTION
WALGREEN 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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WALGREEN CO. SEVERE COLD DM DRUG FACTS
ACTIVE INGREDIENTS (IN EACH PACKET)
Acetaminophen 500 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
PURPOSES
Pain reliever/fever reducer
Cough suppressant
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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ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms
may
include:
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temporarily relieves these symptoms due to a cold:
minor aches and pains
minor sore throat pain
headache
nasal and sinus congestion
cough due to minor throat and bronchial irritation
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
skin reddening
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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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blisters
rash
in a child under 12 years of age
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). If
you are not sure whether a drug contains acetaminophen, ask a doctor
or
pharmacist.
if you are no