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ASP Severe Cold Sparkling Original PowerFast Fizz UI1614456


SPL UNCLASSIFIED SECTION

Drug Facts


OTC - ACTIVE INGREDIENT SECTION

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:

temporarily reduces fever

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

WARNINGS SECTION

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


SPL UNCLASSIFIED SECTION

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


SPL UNCLASSIFIED SECTION

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.


SPL UNCLASSIFIED SECTION

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


OTC - ASK DOCTOR SECTION

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 SECTION

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

taking sedatives or tranquilizers

  • gout
  • diabetes
  • arthritis

OTC - STOP USE SECTION

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

taking sedatives or tranquilizers

  • gout
  • diabetes
  • arthritis

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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


DOSAGE & ADMINISTRATION SECTION

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 SECTION

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


OTC - QUESTIONS SECTION

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

24 EFFERVESCENT TABLETS

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