FDA Label for Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night Product Label
The following document was submitted to the FDA by the labeler of this product Bayer Healthcare Llc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Alka-Seltzer Plus® Severe Cold PowerFast Fizz Day Effervescent Tablets
Alka-Seltzer Plus® Cold PowerFast Fizz Night Effervescent Tablets
Otc - Active Ingredient
Active ingredients (in each tablet) Purposes
Aspirin 325 mg (NSAID)*…….………………………..Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg……………………Cough suppressant
Phenylephrine bitartrate 7.8 mg.......……....…....…………..Nasal decongestant
*nonsteroidal anti-inflammatory drug
Active ingredients (in each tablet) Purposes
Aspirin 325 mg (NSAID)*…….…………………..Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg……..…..……Cough suppressant
Doxylamine succinate 6.25 mg………………..…..………...…Antihistamine
Phenylephrine bitartrate 7.8 mg.......…………..…...….Nasal decongestant
*nonsteroidal anti-inflammatory drug
Indications & Usage
Uses
- temporarily relieves these symptoms due to a cold with cough:
- minor aches and pains
- headache
- sinus congestion and pressure
- cough
- sore throat
- nasal congestion
- temporarily reduces fever
- 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
Uses
Warnings
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
- are age 60 or older
- have had stomach ulcers or bleeding problems
- artake 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
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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
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 itsingredients
● 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
Otc - Ask Doctor
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 that occurs 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
- 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 that occurs 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 before use if
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for
- gout
- diabetes
- arthritis
- taking a prescription drug for
- gout
- diabetes
- arthritis
- taking sedatives or tranquilizers
Ask a doctor or pharmacist before use if you are
Otc - When Using
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
Otc - Stop Use
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
- 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
Otc - Pregnancy Or Breast Feeding
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.
Otc - 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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- do not take more than the recommended dose
- do not take the Day and Night products at the same time; wait 4 hours after taking the last Night dose before taking the Day product
- adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
- children under 12 years: do not use
- do not take more than the recommended dose
- do not take the Day and Night products at the same time; wait 4 hours after taking the last Day dose before taking the Night product
- adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
- children under 12 years: do not use
Directions
Other Safety Information
Other information
- each tablet contains: potassium 78 mg; sodium 356 mg
- store at room temperature. Avoid excessive heat.
- each tablet contains: potassium 78 mg; sodium 356 mg
- store at room temperature. Avoid excessive heat.
Other information
Inactive Ingredient
Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose
Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose
Otc - Questions
Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
Questions or comments? 1-800-986-0369 (Mon-
Fri 9AM – 5PM EST)
Package Label.Principal Display Panel
Alka-Seltzer Plus®
SEVERE COLD
DAY/CITRUS
NIGHT LEMON
POWERFAST FIZZ™
DAY NON-DROWSY
ASPIRIN (NSAID)/Pain Reliever - Fever Reducer
DEXTROMETHORPHAN HBr/Cough Suppressant
PHENYLEPHRINE BITARTRATE/Nasal Decongestant
- Nasal Decongestant
- Headache + Body Ache
- Cough
- Sore Throat
- Sinus Pressure
- Nasal congestion
- Headache + Body Ache
- Cough
- Runny Nose
- Sore Throat
12 EFFERVESCENT TABLETS
NEW NIGHT DOSING DIRECTIONS
NIGHT
Aspirin (NSAID)/Pain Reliever-Fever Reducer
Dextromethorphan HBr/Cough Suppressant
Doxylamine Succinate/Antihistamine
Phenylephrine Bitartrate/Nasal Decongestant
8 EFFERVESCENT TABLETS
* Please review the disclaimer below.