Alka-seltzer Plus Cold Day And Night Kit
FDA Label NDC 0280-1550

Alka-Seltzer Plus® Cold Day Effervescent Tablets

Drug Facts

Alka-Seltzer Plus® Cold Night Effervescent Tablets

SPL

Active ingredients (in each tablet)

Aspirin 325 mg (NSAID)*

Dextromethorphan hydrobromide 10 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

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

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

•temporarily relieves these symptoms due to a cold with cough:

 • minor aches and pains  • headache  • cough

 • nasal and sinus congestion  • 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.

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 with excessive phlegm (mucus)

● 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 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

Ask a doctor or pharmacist before use if you are

● taking a prescription drug for

 ● gout  ● diabetes  ● arthritis

Ask a doctor or pharmacist before use if you are

 taking a prescription drug for

 • gout  • diabetes  • 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

● 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.

● 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 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

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 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.

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.

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

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 416 mg

● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet

● store at room temperature. Avoid excessive heat

Other information

● each tablet contains: sodium 476 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, dimethicone, docusate sodium,

flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Inactive ingredients acesulfame potassium, anhydrous citric

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

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

sodium bicarbonate

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM –

5PM EST)

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

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

Fri 9AM – 5PM EST)

Alka-Seltzer

PLUS®

DAY NON-DROWSY

ASPIRIN (NSAID) / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Phenylephrine Bitartrate / Nasal Decongestant

• Nasal Congestion
• Headache & Body Ache
• Cough
• Sore Throat
• Sinus Pressure

12 EFFERVESCENT TABLETS

NIGHT

ASPIRIN (NSAID) / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate / Antihistamine

Phenylephrine Bitartrate / Nasal Decongestant

• Nasal Congestion
• Headache & Body Ache
• Cough
• Runny nose
• Sore Throat

8 EFFERVESCENT TABLETS



Carton Label (430948 86329123 Asp Cold Day Night Eff Tablet 20ct Crtn Dlp R2 Fda2)