ALKA-SELTZER PLUS MAXIMUM STRENGTH DAY COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

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:

Bayer HealthCare LLC.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant Uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · cough · sore throat · nasal and sinus congestion · temporarily reduces fever 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. ● if you have ever had an allergic reaction to this product or any of its ingredients ● in children under 12 years of age Stop use and ask a doctor if · pain, cough, or nasal congestion gets worse or lasts more than 7 days · fever gets worse or lasts more than 3 days · redness or swelling is present · new symptoms occur · cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. · nervousness, dizziness, or sleeplessness occurs

Authorization status:

OTC monograph final

Summary of Product characteristics

ALKA-SELTZER PLUS MAXIMUM STRENGTH DAY COLD AND FLU-
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE
HYDROCHLORIDE CAPSULE, LIQUID FILLED
BAYER HEALTHCARE LLC.
----------
ALKA-SELTZER PLUS® MAXIMUM STRENGTH DAY COLD & FLU LIQUID GELS
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH CAPSULE)_
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
_PURPOSES_
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
_USES_
· temporarily relieves these symptoms due to a cold or flu:
· minor aches and pains · headache · cough
· sore throat · nasal and sinus congestion
· temporarily reduces fever
_WARNINGS_
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if
you take
· 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 or severe
allergic reactions. Symptoms may include:
· skin reddening · blisters · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic 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
● 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.
● if you have ever had an allergic reaction to this product or any
of its
ingredients
● in children under 12 years of age
ASK A DOCTOR BEFORE