Alka-seltzer Plus Cold Day & Night Effervescent

Alka-seltzer Plus Cold Day & Night Effervescent
SPL v4
SPL
SPL Set ID c478df69-823a-4112-8f44-323249a9f38f
Route
ORAL
Published
Effective Date 2018-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg) Dextromethorphan (10 mg) Phenylephrine (7.8 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Aspartame Calcium Silicate Dimethicone Docusate Sodium Methyl Salicylate Mannitol Povidone Sodium Benzoate Sodium Bicarbonate

Identifiers & Packaging

Pill Appearance
Imprint: ASP;DAY Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-02

Description

Aspirin 325 mg (NSAID)* Dextromethorphan hydrobromide 10 mg Phenylephrine bitartrate 7.8 mg *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Description

Aspirin 325 mg (NSAID)* Dextromethorphan hydrobromide 10 mg Phenylephrine bitartrate 7.8 mg *nonsteroidal anti-inflammatory drug

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

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings

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. Reye’s syndrome:

Aspirin may cause a severe allergic reaction which may include: Allergy alert:

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

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you Stomach bleeding warning:

● 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

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. Sore throat warning:

Do not use to sedate children.

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

Questions?

1-800-986-0369 

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

Other Information

sodium 476 mg ● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet



● each tablet contains:

● store at room temperature. Avoid excessive heat.

Package Labeling:

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, flavors (natural & artificial), mannitol, povidone, sodium benzoate, sodium bicarbonate

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 

● may cause problems in the unborn child or complications during delivery.

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)

● 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

Keep Out of Reach of Children.

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

Active Ingredients (in Each Tablet)

Aspirin 325 mg (NSAID)*

Dextromethorphan hydrobromide 10 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are

● taking a prescription drug for

● gout ● diabetes ● arthritis

● taking sedatives or tranquilizers


Structured Label Content

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

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings

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. Reye’s syndrome:

Aspirin may cause a severe allergic reaction which may include: Allergy alert:

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

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you Stomach bleeding warning:

● 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

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. Sore throat warning:

Do not use to sedate children.

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

Questions?

1-800-986-0369 

Do Not Use  (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

Other Information (Other information)

sodium 476 mg ● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet



● each tablet contains:

● store at room temperature. Avoid excessive heat.

Package Labeling:

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, flavors (natural & artificial), mannitol, povidone, sodium benzoate, sodium bicarbonate

When Using This Product  (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 

● may cause problems in the unborn child or complications during delivery.

Ask A Doctor Before Use If (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)

● 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

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Aspirin 325 mg (NSAID)*

Dextromethorphan hydrobromide 10 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

● taking a prescription drug for

● gout ● diabetes ● arthritis

● taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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