ALKA-SELTZER PLUS COLD SPARKLING ORIGINAL POWERFAST FIZZ- aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent

Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz by

Drug Labeling and Warnings

Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

PURPOSE

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

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

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.

Do not use to sedate children.

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 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

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

• gout
• diabetes
• arthritis

taking sedatives or tranquilizers

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

• gout
• diabetes
• arthritis

taking sedatives or tranquilizers

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.

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

DOSAGE & 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

OTHER SAFETY INFORMATION

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

● store at room temperature. Avoid excessive heat.

INACTIVE INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

ALKA-SELTZER PLUS COLD SPARKLING ORIGINAL POWERFAST FIZZ 
aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0060
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE BITARTRATE	7.8 mg

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CALCIUM SILICATE (UNII: S4255P4G5M)
MANNITOL (UNII: 3OWL53L36A)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	25mm
Flavor	LEMON	Imprint Code	ALKA;SELTZERplus
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-0060-01	10 in 1 CARTON	06/15/2021
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 0280-0060-02	18 in 1 CARTON	06/15/2021
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 0280-0060-03	2 in 1 CARTON	04/01/2022
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 0280-0060-04	12 in 1 CARTON	03/30/2023
4		2 in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 0280-0060-05	2 in 1 POUCH; Type 0: Not a Combination Product	06/15/2021
6	NDC: 0280-0060-06	24 in 1 CARTON	03/30/2023
6		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/15/2021

Labeler - Bayer HealthCare LLC. (112117283)