Alka-Seltzer Plus

Bayer HealthCare LLC, Consumer Care

Alka-Seltzer Plus Night Cold FormulaEffervescent Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

• Alka-Seltzer Plus Uses
• Warnings
  • Reye's syndrome
  • Allergy alert
  • Alcohol warning
  • Sore throat warning
• Directions
• Alka-Seltzer Plus Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL - Shipper Label

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Alka-Seltzer Plus Uses

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

Warnings

Reye's syndrome

Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

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

Alcohol warning

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

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.
• in children under 12 years of age

Ask a doctor before use if you have

• stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
• bleeding problems
• ulcers
• asthma
• heart disease
• high blood pressure
• diabetes
• thyroid disease
• glaucoma
• cough with excessive phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for
  • anticoagulation (blood thinning)
  • diabetes
  • gout
  • arthritis
• taking sedatives or tranquilizers

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

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
• 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 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

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.

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 at bedtime (may be taken every 4 to 6 hours). Do not exceed 8 tablets in 24 hours or as directed by a doctor.
• children under 12 years: do not use

Alka-Seltzer Plus Other information

• each tablet contains: sodium 474 mg
• Phenylketonurics: Contains Phenylalanine 5.6 mg per tablet
• store at room temperature. Avoid excessive heat.

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Questions or comments?

1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzerplus.com

PRINCIPAL DISPLAY PANEL - Shipper Label

ALKA-SELTZER PLUS^®
NIGHT COLD FORMULA

3200 TABLETS 1600 PIECES

SHIPPER
CODE
1 00 16500 54213 8

MADE IN
MEXICO

PRODUCT CODE

82411594

STORE AT ROOM
TEMPERATURE.
AVOID EXCESSIVE HEAT

Bayer HealthCare LLC
Consumer Care
P.O. Box 1910, Morristown, NJ
07962-1910 USA