Alka-Seltzer Plus® Cold Night Effervescent Tablets

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Aspirin 500 mg (NSAID)*

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

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 SECTION

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.

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 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 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

● taking a prescription drug for

● gout ● diabetes ● arthritis

● 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 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

● 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 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.

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

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

Other information

● each tablet contains: sodium 476 mg

● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet

● store at room temperature. Avoid excessive heat.

INACTIVE INGREDIENT SECTION

Inactive ingredients acesulfame potassium, anhydrous citric

acid, aspartame, calcium silicate, dimethicone, docusate sodium,

flavors (natural & artificial), mannitol, povidone, sodium benzoate,

sodium bicarbonate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka-Seltzer

Plus ®

Cold

Night

Lemon

ASPIRIN ( NSAID) / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate / Antihistamine

Phenylephrine Bitartrate / Nasal Decongestant

20 EFFERVESCENT TABLETS

Nasal Congestion
Headache & Body Ache
Cough
Runny Nose
Sore Throat

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