Alka Seltzer Cold Cold And Headache Maximum Strength Fast Dissolve Tablet, Effervescent
FDA Label NDC 0280-8266

Drug Facts

Active ingredients (in each tablet)

Aspirin 325 mg (NSAID)*

Chlorpheniramine maleate 2 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses

· temporarily relieves these symptoms due to a cold:

· minor aches and pains · headache · runny nose

· nasal congestion · sinus congestion and pressure · sneezing · sore throat

· 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: 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

● a breathing problem such as emphysema or chronic bronchitis

● difficulty in urination due to enlargement of the prostate gland

● a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

· taking a prescription drug for diabetes, gout or arthritis

· taking sedatives or tranquilizers

When using this product

● do not exceed recommended dosage

● may cause drowsiness

● alcohol, sedatives, and tranquilizers may increase the drowsiness effect

● avoid alcoholic drinks

● be careful when driving a motor vehicle or operating machinery

● excitability may occur, especially in children

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 stools

● have stomach pain that does not get better

● pain 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

● nervousness, dizziness, or sleeplessness occur

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.

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

● store between 20 ^oC to 25 ^oC (68 ^oF to 77 ^oF). Avoid excessive heat above 40 ^oC (104 ^oF).

Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Questions or comments? 1-800-986-0369 (Mon – Fri 8AM – 8PM EST)