Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night Effervescent Tablets Ui 1614460 & 161897

Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night Effervescent Tablets Ui 1614460 & 161897
SPL v5
SPL
SPL Set ID c2232241-6e57-1427-e053-2995a90a488a
Route
ORAL
Published
Effective Date 2021-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg) Dextromethorphan (10 mg) Phenylephrine (7.8 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Mannitol Potassium Bicarbonate Povidone Sodium Bicarbonate Calcium Silicate Fd&c Red No. 40 Fd&c Yellow No. 6 Sucralose Anhydrous Citric Acid Dimethicone

Identifiers & Packaging

Pill Appearance
Imprint: ASP;NT Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-05

Description

Drug Facts Alka-Seltzer Plus® Severe Cold PowerFast Fizz Day Effervescent Tablets


Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses

  • temporarily relieves these symptoms due to a cold with cough:
    • minor aches and pains
    • headache
    • sinus congestion and pressure
    • cough
    • sore throat
    • nasal congestion
  • temporarily reduces fever
Dosage and Administration

Directions

  • do not take more than the recommended dose
  • do not take the Day and Night products at the same time; wait 4 hours after taking the last Night dose before taking the Day product
  • adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
  • children under 12 years: do not use
Description

Drug Facts Alka-Seltzer Plus® Severe Cold PowerFast Fizz Day Effervescent Tablets

Section 42229-5

Drug Facts

Alka-Seltzer Plus® Severe Cold PowerFast Fizz Day Effervescent Tablets

Section 50565-1

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

Section 50566-9

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 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
Section 50567-7

When using this product do not exceed recommended dosage.

Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for
    • gout
    • diabetes
    • arthritis
Section 50569-3

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 that occurs 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
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 itsingredients

● in children under 12 years of age

Section 51727-6

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 51945-4

Alka-Seltzer Plus®

SEVERE COLD

DAY/CITRUS

NIGHT LEMON

POWERFAST FIZZ™

DAY NON-DROWSY

ASPIRIN (NSAID)/Pain Reliever - Fever Reducer

DEXTROMETHORPHAN HBr/Cough Suppressant

PHENYLEPHRINE BITARTRATE/Nasal Decongestant

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

12 EFFERVESCENT TABLETS

NEW NIGHT DOSING DIRECTIONS

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

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.

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.

Section 55106-9

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

Section 60561-8

Other information

  • each tablet contains: potassium 78 mg; sodium 356 mg
  • store at room temperature. Avoid excessive heat.

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves these symptoms due to a cold with cough:
    • minor aches and pains
    • headache
    • sinus congestion and pressure
    • cough
    • sore throat
    • nasal congestion
  • temporarily reduces fever
Dosage and Administration (34068-7)

Directions

  • do not take more than the recommended dose
  • do not take the Day and Night products at the same time; wait 4 hours after taking the last Night dose before taking the Day product
  • adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
  • children under 12 years: do not use
Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Drug Facts

Alka-Seltzer Plus® Severe Cold PowerFast Fizz Day Effervescent Tablets

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.

Section 50566-9 (50566-9)

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 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
Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for
    • gout
    • diabetes
    • arthritis
Section 50569-3 (50569-3)

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 that occurs 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
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 itsingredients

● in children under 12 years of age

Section 51727-6 (51727-6)

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 51945-4 (51945-4)

Alka-Seltzer Plus®

SEVERE COLD

DAY/CITRUS

NIGHT LEMON

POWERFAST FIZZ™

DAY NON-DROWSY

ASPIRIN (NSAID)/Pain Reliever - Fever Reducer

DEXTROMETHORPHAN HBr/Cough Suppressant

PHENYLEPHRINE BITARTRATE/Nasal Decongestant

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

12 EFFERVESCENT TABLETS

NEW NIGHT DOSING DIRECTIONS

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

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.

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.

Section 55106-9 (55106-9)

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

Section 60561-8 (60561-8)

Other information

  • each tablet contains: potassium 78 mg; sodium 356 mg
  • store at room temperature. Avoid excessive heat.

Advanced Ingredient Data


Raw Label Data

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