alksa-seltzer plus severe cold powerfast fizz day and night effervescent tablets ui 1614458 & 1614460

alksa-seltzer plus severe cold powerfast fizz day and night effervescent tablets ui 1614458 & 1614460
SPL v4
SPL
SPL Set ID a37c9d9d-52db-23ff-e053-2995a90a8f76
Route
oral
Published
Effective Date 2020-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aspirin (325 mg) phenylephrine (7.8 mg) dextromethorphan (10 mg) doxylamine (500 mg)
Inactive Ingredients
mannitol potassium bicarbonate anhydrous citric acid dimethicone fd&c red no. 40 sucralose fd&c yellow no. 6 povidone sodium bicarbonate calcium silicate

Identifiers & Packaging

Pill Appearance
Imprint: ASP;NT Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-04-01

Description

Alka-Seltzer Plus Severe cold PowerFast Fizz Day Effervescent Tablets


Medication Information

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.

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

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

Other Information

Other information

each tablet contains: potassium 80 mg; sodium 356 mg

● store at room temperature. Avoid excessive heat.

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

Description

Alka-Seltzer Plus Severe cold PowerFast Fizz Day Effervescent Tablets

Section 50570-1

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

Product

Alka-Seltzer Plus Severe cold PowerFast Fizz Day Effervescent Tablets

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

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

Drug Facts

Drug Facts

When Using

When using this product do not exceed recommended dosage

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

Package Display

Alka-Seltzer

Plus®

SEVERE

Cold

POWERFAST FIZZ™

DAY/CITRUS

NIGHT/LEMON

NEW IMPROVED FLAVOR

DAY NON-DROWSY

ASPIRIN (NSAID) / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Phenylephrine Bitartrate / Nasal Decongestant

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

12 EFFERVESCENT TABLETS

NIGHT

ASPIRIN (NSAID) / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate / Antihistamine

Phenylephrine Bitartrate / Nasal Decongestant

  • Nasal Congestion
  • Headache + Body Ache
  • Cough
  • Runny Nose
  • Sore Throat

8 EFFERVESCENT TABLETS

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

Questions Or Comments

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

When Using This Product

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

Pregnant Or Breastfeeding

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.

Ask A Doctor Or Pharmacist

Ask a doctor or pharmacist before use if you are

· taking a prescription drug for

· gout · diabetes · arthritis

Stop Use and Ask A Doctor If

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

If 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.

Keep Out of Reach of Children

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


Structured Label Content

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.

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

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

Other Information (Other information)

Other information

each tablet contains: potassium 80 mg; sodium 356 mg

● store at room temperature. Avoid excessive heat.

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

Section 50570-1 (50570-1)

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

Product

Alka-Seltzer Plus Severe cold PowerFast Fizz Day Effervescent Tablets

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

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

Drug Facts

Drug Facts

When Using (When using)

When using this product do not exceed recommended dosage

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

Package Display (Package display)

Alka-Seltzer

Plus®

SEVERE

Cold

POWERFAST FIZZ™

DAY/CITRUS

NIGHT/LEMON

NEW IMPROVED FLAVOR

DAY NON-DROWSY

ASPIRIN (NSAID) / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Phenylephrine Bitartrate / Nasal Decongestant

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

12 EFFERVESCENT TABLETS

NIGHT

ASPIRIN (NSAID) / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate / Antihistamine

Phenylephrine Bitartrate / Nasal Decongestant

  • Nasal Congestion
  • Headache + Body Ache
  • Cough
  • Runny Nose
  • Sore Throat

8 EFFERVESCENT TABLETS

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

Questions Or Comments (Questions or comments)

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

When Using This Product (When using this product)

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

Pregnant Or Breastfeeding (Pregnant or breastfeeding)

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.

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding (If 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.

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)