Asp Severe Cold Sparkling Original Powerfast Fizz Ui1614456

SPL v7

SPL

SPL Set ID bd49121c-7cba-c51f-e053-2995a90a921e

Route

ORAL

Published

Effective Date 2021-05-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Aspirin (325 mg) Chlorpheniramine (2 mg) Phenylephrine (7.8 mg)

Inactive Ingredients

Dimethicone Potassium Bicarbonate Sucralose Anhydrous Citric Acid Calcium Silicate Mannitol Sodium Bicarbonate Povidone

Identifiers & Packaging

Pill Appearance

Imprint: ALKA;SELTZERplus 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

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.

Dosage and Administration

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

Description

Drug Facts

Uses

temporarily relieves these symptoms due to a cold:

minor aches and pains
headache
runny nose
nasal congestion
sneezing
sore throat
sinus congestion and pressure

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.

Section 50566-9

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout
diabetes
arthritis

taking sedatives or tranquilizers

Section 50568-5

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout
diabetes
arthritis

taking sedatives or tranquilizers

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

● diabetes

● thyroid disease

● glaucoma

● difficulty in urination due to enlargement of the prostate gland

● a breathing problem such as emphysema or chronic bronchitis

● a sodium-restricted diet

Section 51727-6

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

Section 51945-4

Alka-Seltzer Plus®

Severe Cold

Sparkling Original

POWERFAST FIZZ™

NEW LESS RESIDUE

ASPIRIN (NSAID)/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Phenylephrine Bitartrate/Nasal Decongestant

Nasal Congestion
Runny Nose
Sore Throat
Headache + Body Ache
Sinus Pressure

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.

It is especially important not to use aspirin at 20 weeks or later in 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

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

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

*nonsteroidal anti-inflammatory drug

Section 60561-8

Other information

● each tablet contains: potassium 80 mg; sodium 356 mg

● store at room temperature. Avoid excessive heat.

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

Allergy Alert

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

● hives

● facial swelling

● asthma (wheezing)

● shock

Structured Label Content

Uses

temporarily relieves these symptoms due to a cold:

minor aches and pains
headache
runny nose
nasal congestion
sneezing
sore throat
sinus congestion and pressure

temporarily reduces fever

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Section 50566-9 (50566-9)

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout
diabetes
arthritis

taking sedatives or tranquilizers

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout
diabetes
arthritis

taking sedatives or tranquilizers

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

● diabetes

● thyroid disease

● glaucoma

● difficulty in urination due to enlargement of the prostate gland

● a breathing problem such as emphysema or chronic bronchitis

● a sodium-restricted diet

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Alka-Seltzer Plus®

Severe Cold

Sparkling Original

POWERFAST FIZZ™

NEW LESS RESIDUE

ASPIRIN (NSAID)/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Phenylephrine Bitartrate/Nasal Decongestant

Nasal Congestion
Runny Nose
Sore Throat
Headache + Body Ache
Sinus Pressure

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

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

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

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

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

Other information

● each tablet contains: potassium 80 mg; sodium 356 mg

● store at room temperature. Avoid excessive heat.

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

Allergy Alert (Allergy alert)

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

● hives

● facial swelling

● asthma (wheezing)

● shock

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:28.986352 · Updated: 2026-03-14T23:11:00.469021