FDA Label for Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- USES
- WARNINGS
- ALLERGY ALERT
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz Product Label
The following document was submitted to the FDA by the labeler of this product Bayer Healthcare Llc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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.
Otc - 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
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
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
Otc - Ask 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
● 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- gout
- diabetes
- arthritis
taking sedatives or tranquilizers
Otc - Stop Use
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- gout
- diabetes
- arthritis
taking sedatives or tranquilizers
Otc - Pregnancy 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.
Otc - 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.
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 78 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
Otc - Questions
Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
Package Label.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
20 EFFERVESCENT TABLETS
* Please review the disclaimer below.