FDA Label for Alka-seltzer Plus Maximum Strength Day And Night Cold And Flu
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- 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
- OTC - ASK DOCTOR/PHARMACIST
- DIRECTIONS
- OTHER INFORMATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Alka-seltzer Plus Maximum Strength Day And Night Cold And Flu 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
Maximum Strength Day & Night Cold & Flu Liquid Gels
Alka-Seltzer Plus® Maximum Strength Night Cold & Flu Liquid Gels
Otc - Active Ingredient
Active ingredients (in each capsule) Purposes
Acetaminophen 325 mg…………….……….Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg…………..Cough suppressant
Phenylephrine hydrochloride 5 mg…………………Nasal decongestant
Active ingredients (in each capsule) Purposes
Acetaminophen 325 mg…………….………...Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg……………Cough suppressant
Doxylamine succinate 6.25 mg……………………………...Antihistamine
Phenylephrine hydrochloride 5 mg.....……………...Nasal decongestant
Indications & Usage
Uses
· temporarily relieves these symptoms due to a cold or flu:
· minor aches and pains · headache · cough
· sore throat · nasal and sinus congestion
· temporarily reduces fever
Uses
· temporarily relieves these symptoms due to a cold or flu:
· minor aches and pains · headache
· nasal and sinus congestion · cough · sore throat
· runny nose · sneezing
· temporarily reduces fever
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
· more than 4,000 mg of acetaminophen in 24 hours
· with other drugs containing acetaminophen
· 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin or severe
allergic reactions. Symptoms may include:
· skin reddening · blisters · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
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
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
· more than 4,000 mg of acetaminophen in 24 hours
· with other drugs containing acetaminophen
· 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin or severe
allergic reactions. Symptoms may include:
· skin reddening · blisters · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
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
● with any other drug containing acetaminophen (prescription or
nonprescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist.
● 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
● with any other drug containing acetaminophen (prescription or
nonprescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist.
● 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 you have
● liver disease ● heart disease ● high blood pressure
● 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
Ask a doctor before use if you have
● liver disease ● heart disease ● high blood pressure
● thyroid disease ● diabetes ● 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
Otc - When Using
When using this product do not exceed recommended dosage.
Otc - Stop Use
Stop use and ask a doctor if
· 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
· 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
· 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
· cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
· nervousness, dizziness, or sleeplessness occurs
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
If pregnant or breast-feeding, ask a health professional before use.
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
· do not take more than the recommended dose
· adults and children 12 years and over: take 2 capsules with water
every 4 hours. Do not exceed 10 capsules in 24 hours or as
directed by a doctor.
· children under 12 years: do not use
Other Safety Information
Other information
● store at room temperature. Avoid excessive heat above 40°C
(104°F).
Inactive Ingredient
Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
Inactive ingredients D&C yellow #10, FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
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)
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
● taking the blood thinning drug warfarin
● taking sedatives or tranquilizers
Directions
Directions
· do not take more than the recommended dose
· adults and children 12 years and over: take 2 capsules with water
every 4 hours. Do not exceed 10 capsules in 24 hours or as
directed by a doctor.
· children under 12 years: do not use
Other Information
Other information
● store at room temperature. Avoid excessive heat above 40°C
(104°F).
Package Label.Principal Display Panel
Alka-Seltzer Plus®
DAY NON-DROWSY
ACETAMINOPHEN / Pain Reliever-Fever Reducer
Dextromethorphan HBr / Cough Suppresant
Phenylephrine HCl / Nasal Decongestant
- Nasal Congestion
- Headache & Body Ache
- Cough
- Sore Throat
- Sinus Congestion
- Nasal Congestion
- Headache & Body Ache
- Cough
- Runny Nose
- Sore Throat
12 LIQUID GELS
(LIQUID-FILLED CAPSULES)
Night
ACETAMINOPHEN / Pain Reliever-Fever Reducer
Dextromethorphan HBr / Cough Suppresant
Doxylamine Succinate / Antihistamine
Phenylephrine HCl / Nasal Decongestant
8 LIQUID GELS
(LIQUID FILLED CAPSULES)
* Please review the disclaimer below.