ALKA-SELTZER PLUS MAXIMUM STRENGTH SEVERE SINUS, ALLERGY AND COUGH- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, 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), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Bayer HealthCare LLC.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purposes Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestan Uses · temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: · runny nose · sneezing · itching of the nose or throat · itchy, watery eyes · temporarily relieves these symptoms due to a cold: · nasal congestion · sinus congestion and pressure · headache · minor aches and pains · cough · 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 SEVERE SINUS, ALLERGY AND
COUGH- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE
SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED
BAYER HEALTHCARE LLC.
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ALKA-SELTZER PLUS® MAXIMUM STRENGTH SEVERE SINUS, ALLERGY & COUGH
LIQUID
GELS
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH CAPSULE)_
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg
_PURPOSES_
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestan
USES
_USES_
· temporarily relieves these symptoms due to hay fever or other upper
respiratory allergies:
· runny nose · sneezing
· itching of the nose or throat · itchy, watery eyes
· temporarily relieves these symptoms due to a cold:
· nasal congestion · sinus congestion and pressure
· headache · minor aches and pains · cough
· 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
· 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.
DO NOT USE TO SEDATE CHILDREN.
_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 d