alka-seltzer plus® cold day & night effervescent tablets

alka-seltzer plus® cold day & night effervescent tablets
SPL v6
SPL
SPL Set ID 75894849-a0ba-57be-e053-2a91aa0a049a
Route
oral
Published
Effective Date 2018-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
phenylephrine (7.8 mg) aspirin (325 mg) dextromethorphan (10 mg) doxylamine (6.25 mg)
Inactive Ingredients
sodium bicarbonate calcium silicate sodium benzoate acesulfame potassium docusate sodium mannitol povidone anhydrous citric acid aspartame dimethicone

Identifiers & Packaging

Pill Appearance
Imprint: ASP;NT Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
otc monograph drug active Since 2018-09-14

Description

Alka-Seltzer Plus® Cold Day Effervescent Tablets


Medication Information

Warnings and Precautions

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.

Active Ingredient

Active ingredients (in each tablet)

Aspirin 325 mg (NSAID)*

Dextromethorphan hydrobromide 10 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

Uses

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

Indications and Usage

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

Directions

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

Other information

each tablet contains: sodium 416 mg

● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet

● store at room temperature. Avoid excessive heat

Description

Alka-Seltzer Plus® Cold Day Effervescent Tablets

Section 42229-5

Alka-Seltzer Plus® Cold Day Effervescent Tablets

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

When using this product do not exceed recommended dosage

Section 50568-5

Ask a doctor or pharmacist before use if you are

● taking a prescription drug for

 ● gout  ● diabetes  ● arthritis

Section 50569-3

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

Section 50570-1

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

Section 51727-6

Inactive ingredients acesulfame potassium, anhydrous citric

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

flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Section 53413-1

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

5PM EST)

Section 53414-9

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.

Section 55105-1

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Package Display Label

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

Questions Or Comments?

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

Fri 9AM – 5PM EST)


Structured Label Content

Warnings and Precautions (34071-1)

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.

Active Ingredient (55106-9)

Active ingredients (in each tablet)

Aspirin 325 mg (NSAID)*

Dextromethorphan hydrobromide 10 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

Uses

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

Indications and Usage (34067-9)

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

Directions

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 (Other information)

Other information

each tablet contains: sodium 416 mg

● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet

● store at room temperature. Avoid excessive heat

Section 42229-5 (42229-5)

Alka-Seltzer Plus® Cold Day Effervescent Tablets

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

● taking a prescription drug for

 ● gout  ● diabetes  ● arthritis

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients acesulfame potassium, anhydrous citric

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

flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Section 53413-1 (53413-1)

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

5PM EST)

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Package Display Label

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

Questions Or Comments? (Questions or comments?)

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

Fri 9AM – 5PM EST)


Advanced Ingredient Data


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