Alka-Selzer Plus Severe Cold PowerFast Fizz Night effervescent tablets UI 1614459

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

Dextromethorphan hydrobromide 10 mg……………Cough suppressant

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

*nonsteroidal anti-inflammatory drug

INDICATIONS & USAGE SECTION

Uses

• temporarily relieves these symptoms due to a cold: minor aches and pains headache runny nose sinus congestion and pressurecoughsneezingsore throatnasal congestion
• temporarily reduces fever

WARNINGS SECTION

WarningsReye’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:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

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.

• hives
• facial swelling
• asthma (wheezing)
• shock

OTC - DO NOT USE SECTION

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 heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking a diureticyou have asthmadiabetesthyroid diseaseglaucomacough that occurs with excessive phlegm (mucus)a breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glandpersistent or chronic cough such as occurs with smoking, asthma, or emphysemaa sodium-restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for goutdiabetesarthritis
• taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

• do not exceed recommended dosage
• may cause marked drowsiness
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

OTC - STOP USE SECTION

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 stoolshave 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 a 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

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 of age: 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)

Carton 24 count

Alka-Seltzer Plus®

SEVERE

Cold

LEMON

POWERFAST FIZZ™ SEE NEW DOSING DIRECTIONS

NIGHT

Aspirin (NSAID)/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate / Antihistmine

Dextromethorphan HBr / Cough Suppressant

Phenylephrine Bitartrate / Nasal Decongestant

24 EFFERVESCENT TABLETS

• Nasal Congestion
• Headache + Body Ache
• Cough
• Runny Nose
• Sore Throat