Alka Seltzer Cold Cold Congestion Severe Day Night Fast Dissolve Kit
FDA Label NDC 0280-8285

Drug Facts

Alka-Seltzer Cold Cold + Congestion Severe Day Effervescent Tablets

Alka-Seltzer Cold Cold + Congestion Severe Night Fast Dissolve Effervescent Tablets

Active ingredients (in each tablet) Purposes

Aspirin 325 mg (NSAID)*…….………………………..Pain reliever/fever reducer

Dextromethorphan hydrobromide 10 mg……………………Cough suppressant

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

*nonsteroidal anti-inflammatory drug

Active ingredients (in each tablet) Purposes

Aspirin 325 mg (NSAID)*…….…………………..Pain reliever/fever reducer

Chlorpheniramine maleate 2mg ……….……..…..………...…Antihistamine

Dextromethorphan hydrobromide 10 mg……..…..……Cough suppressant

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
  • sinus congestion and pressure
  • cough
  • sore throat
  • nasal congestion
  • temporarily reduces fever

  Uses

  • temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • headache
    • runny nose
    • sinus congestion and pressure
    • cough
    • sneezing
    • sore throat
    • nasal congestion
    • 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.

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

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 •thyroid disease • diabetes
  • cough that is accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • difficulty in urination due to enlargement of the prostate gland
  • a sodium-restricted diet

  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
    • cough that is accompanied by excessive phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma,or emphysema
    • 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

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.

When using this product

• do not exceed recommended dosage
• may cause marked 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, 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
  • cough comes back or occurs with rash or headache that lasts. These
  • could be signs of a serious condition.
  • ringing in the ears or loss of hearing occurs
  • nervousness, dizziness, or sleeplessness occurs

  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, 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
    • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
    • ringing in the ears or loss of hearing occurs
    • nervousness, dizziness, or sleeplessness occurs

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.

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.

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

Directions

• do not take more than the recommended dose
• 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

Directions

• do not take more than the recommended dose
• 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 ^o​F).

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 ^o​F).

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

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

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

Questions or comments? 1-800-986-0369 (Mon-

Fri 8AM – 8PM EST)

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