Alka-seltzer Plus Severe Cold Powerfast Fizz Non Drowsy Effervescent Tablets Ui1614460

Alka-seltzer Plus Severe Cold Powerfast Fizz Non Drowsy Effervescent Tablets Ui1614460
SPL v4
SPL
SPL Set ID a355d987-77ce-9e32-e053-2995a90a6431
Route
ORAL
Published
Effective Date 2020-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg) Phenylephrine (7.8 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Mannitol Sodium Bicarbonate Calcium Silicate Dimethicone Fd&c Red No. 40 Anhydrous Citric Acid Fd&c Yellow No. 6 Povidone, Unspecified Sucralose Potassium Bicarbonate

Identifiers & Packaging

Pill Appearance
Imprint: ASP Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

Uses

· temporarily relieves these symptoms due to a cold with cough:

· minor aches and pains · headache · cough

· nasal and sinus congestion · sore throat

· temporarily reduces fever

Section 42229-5

Drug Facts

Stop Use

Stop use and ask a doctor if

· an allergic reaction occurs. Seek medical help right away.

● you experience any of the following signs of stomach bleeding

● feel faint ● vomit blood ● have bloody or black stools

● have stomach pain that does not get better

· 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

· ringing in the ears or a loss of hearing occurs

· cough comes back or occurs with rash or headache that lasts. These

could be signs of a serious condition.

· nervousness, dizziness, or sleeplessness occurs

Warnings

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

· hives · facial swelling · asthma (wheezing) · shock

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

● are age 60 or older

● have had stomach ulcers or bleeding problems

● take a blood thinning (anticoagulant) or steroid drug

● take other drugs containing prescription or nonprescription NSAIDs

(aspirin, ibuprofen, naproxen, or others)

● have 3 or more alcoholic drinks every day while using this product

● take more or for a longer time than directed

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.

Questions

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

Directions

Directions

● adults and children 12 years and over: take 2 tablets fully dissolved

in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours

or as directed by a doctor.

● children under 12 years: do not use

Do Not Use

Do not use

● if you are allergic to aspirin or any other pain reliever/fever reducer

● 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

Ask a doctor before use if

● stomach bleeding warning applies to you

● you have a history of stomach problems, such as heartburn

● you have high blood pressure, heart disease, liver cirrhosis,

or kidney disease

● you are taking a diuretic

● you have

● asthma ● thyroid disease ● diabetes

● cough with excessive phlegm (mucus)

● difficulty in urination due to enlargement of the prostate gland

● persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

● a sodium-restricted diet

Carton 20 Count

Alka-Seltzer Plus®

SEVERE

Cold

CITRUS

POWERFAST™ FIZZ

NEW IMPROVED FLAVOR

NON-DROWSY

ASPIRIN (NSAID) / Pain Reliever-Fever Reducer

Dextromehorphan HBr / Cough Suppressant

Phenylephrine Bitartrate / Nasal Decongestant

  • Fever + Body Ache
  • Nasal Congestion
  • Sinus Pressure
  • Sore Throat
  • Cough

20 EFFERVESCENT TABLETS

Keep Out of Reach

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Other Information

Other information

each tablet contains: potassium 80 mg; sodium 356 mg

● store at room temperature. Avoid excessive heat.

Active Ingredients

Active ingredients (in each tablet) Purposes

Aspirin 325 mg (NSAID)*…….……………….Pain reliever/fever reducer

Dextromethorphan hydrobromide 10 mg……………Cough suppressant

Phenylephrine bitartrate 7.8 mg.......……....…...…..Nasal decongestant

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

When Using This Product

When using this product do not exceed recommended dosage

Ask A Doctor Or Pharmacist

Ask a doctor or pharmacist before use if you are

· taking a prescription drug for

· gout · diabetes · arthritis

Pregnant Or Breast Feeding

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

It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.


Structured Label Content

Uses

Uses

· temporarily relieves these symptoms due to a cold with cough:

· minor aches and pains · headache · cough

· nasal and sinus congestion · sore throat

· temporarily reduces fever

Section 42229-5 (42229-5)

Drug Facts

Stop Use (Stop use)

Stop use and ask a doctor if

· an allergic reaction occurs. Seek medical help right away.

● you experience any of the following signs of stomach bleeding

● feel faint ● vomit blood ● have bloody or black stools

● have stomach pain that does not get better

· 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

· ringing in the ears or a loss of hearing occurs

· cough comes back or occurs with rash or headache that lasts. These

could be signs of a serious condition.

· nervousness, dizziness, or sleeplessness occurs

Warnings

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

· hives · facial swelling · asthma (wheezing) · shock

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

● are age 60 or older

● have had stomach ulcers or bleeding problems

● take a blood thinning (anticoagulant) or steroid drug

● take other drugs containing prescription or nonprescription NSAIDs

(aspirin, ibuprofen, naproxen, or others)

● have 3 or more alcoholic drinks every day while using this product

● take more or for a longer time than directed

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.

Questions

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

Directions

Directions

● adults and children 12 years and over: take 2 tablets fully dissolved

in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours

or as directed by a doctor.

● children under 12 years: do not use

Do Not Use (Do not use)

Do not use

● if you are allergic to aspirin or any other pain reliever/fever reducer

● 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 (Ask a doctor)

Ask a doctor before use if

● stomach bleeding warning applies to you

● you have a history of stomach problems, such as heartburn

● you have high blood pressure, heart disease, liver cirrhosis,

or kidney disease

● you are taking a diuretic

● you have

● asthma ● thyroid disease ● diabetes

● cough with excessive phlegm (mucus)

● difficulty in urination due to enlargement of the prostate gland

● persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

● a sodium-restricted diet

Carton 20 Count (Carton 20 count)

Alka-Seltzer Plus®

SEVERE

Cold

CITRUS

POWERFAST™ FIZZ

NEW IMPROVED FLAVOR

NON-DROWSY

ASPIRIN (NSAID) / Pain Reliever-Fever Reducer

Dextromehorphan HBr / Cough Suppressant

Phenylephrine Bitartrate / Nasal Decongestant

  • Fever + Body Ache
  • Nasal Congestion
  • Sinus Pressure
  • Sore Throat
  • Cough

20 EFFERVESCENT TABLETS

Keep Out of Reach (Keep out of reach)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Other Information (Other information)

Other information

each tablet contains: potassium 80 mg; sodium 356 mg

● store at room temperature. Avoid excessive heat.

Active Ingredients (Active ingredients)

Active ingredients (in each tablet) Purposes

Aspirin 325 mg (NSAID)*…….……………….Pain reliever/fever reducer

Dextromethorphan hydrobromide 10 mg……………Cough suppressant

Phenylephrine bitartrate 7.8 mg.......……....…...…..Nasal decongestant

*nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

When Using This Product (When using this product)

When using this product do not exceed recommended dosage

Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

Ask a doctor or pharmacist before use if you are

· taking a prescription drug for

· gout · diabetes · arthritis

Pregnant Or Breast Feeding (Pregnant or breast feeding)

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

It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)