alka-seltzer plus® cold day & night effervescent tablets
75894849-a0ba-57be-e053-2a91aa0a049a
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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)
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Source: dailymed · Ingested: 2026-02-15T12:07:30.011619 · Updated: 2026-03-14T23:11:02.639613