Asp Maximum Strength Sinus Congestion And Pain Powerfast Fizz Ui1614734

Asp Maximum Strength Sinus Congestion And Pain Powerfast Fizz Ui1614734
SPL v6
SPL
SPL Set ID bd97e91f-1ae1-379c-e053-2995a90acfdd
Route
ORAL
Published
Effective Date 2021-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (2 mg) Phenylephrine (5 mg) Dextromethorphan (10 mg) Acetaminophen (325 mg)
Inactive Ingredients
Calcium Silicate Mannitol Magnesium Stearate Potassium Bicarbonate Sodium Bicarbonate Sucralose Povidone, Unspecified Maltodextrin Anhydrous Citric Acid Dimethicone

Identifiers & Packaging

Pill Appearance
Imprint: SINUS Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-15

Description

Drug Facts


Medication Information

Warnings and Precautions

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 to sedate children.

Dosage and Administration

Directions

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 10 tablets in 24 hours or as directed by a doctor.
  • children under 12 years: do not use
Description

Drug Facts

Uses

temporarily relieves these symptoms due to a cold or flu:

  • minor aches and pains
  • headache
  • cough
  • sore throat
  • runny nose
  • sneezing
  • nasal congestion · sinus

temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

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
Section 50567-7

When using this product

  • do not exceed recommended dosage
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50570-1

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
Section 51727-6

Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Section 51945-4

Alka-Seltzer Plus®

MAXIMUM STRENGTH

Sinus

Congestion

& Pain

PowerFast Fizz™

Berry

New!

Actaminophen/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Supressant

Phenylephrine Hydrochloride/Nasal Decongestant

  • Sinus Congestion & Pressure
  • Nasal Congestion
  • Headache, Body Ache, Sore Throat
  • Runny Nose, Sneezing
  • Cough

24 EFFERVESCENT TABLETS

Section 53413-1

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55106-9

Active ingredients (in each tablet) Purposes

Acetaminophen 325 mg…………….………...Pain reliever/fever reducer

Chlorpheniramine maleate 2 mg……………………..……..Antihistamine

Dextromethorphan hydrobromide 10 mg……………Cough suppressant

Phenylephrine hydrochloride 5 mg………………….Nasal decongestant

Section 60561-8

Other information

each tablet contains: potassium 80 mg; sodium 356 mg

store at room temperature. Avoid excessive heat.


Structured Label Content

Uses

temporarily relieves these symptoms due to a cold or flu:

  • minor aches and pains
  • headache
  • cough
  • sore throat
  • runny nose
  • sneezing
  • nasal congestion · sinus

temporarily reduces fever

Dosage and Administration (34068-7)

Directions

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 10 tablets in 24 hours or as directed by a doctor.
  • children under 12 years: do not use
Warnings and Precautions (34071-1)

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 to sedate children.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product

  • do not exceed recommended dosage
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Section 51945-4 (51945-4)

Alka-Seltzer Plus®

MAXIMUM STRENGTH

Sinus

Congestion

& Pain

PowerFast Fizz™

Berry

New!

Actaminophen/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Supressant

Phenylephrine Hydrochloride/Nasal Decongestant

  • Sinus Congestion & Pressure
  • Nasal Congestion
  • Headache, Body Ache, Sore Throat
  • Runny Nose, Sneezing
  • Cough

24 EFFERVESCENT TABLETS

Section 53413-1 (53413-1)

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55106-9 (55106-9)

Active ingredients (in each tablet) Purposes

Acetaminophen 325 mg…………….………...Pain reliever/fever reducer

Chlorpheniramine maleate 2 mg……………………..……..Antihistamine

Dextromethorphan hydrobromide 10 mg……………Cough suppressant

Phenylephrine hydrochloride 5 mg………………….Nasal decongestant

Section 60561-8 (60561-8)

Other information

each tablet contains: potassium 80 mg; sodium 356 mg

store at room temperature. Avoid excessive heat.


Advanced Ingredient Data


Raw Label Data

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