FDA Label for Alka-seltzer Plus Cough, Mucus And Congestion Day And Night Powermax
View Indications, Usage & Precautions
- OTHER
- PRODUCT NAME
- ACTIVE INGREDIENTS AND PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- PRODUCT CARTON LABEL 24 COUNT
Alka-seltzer Plus Cough, Mucus And Congestion Day And Night Powermax 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
Product Name
Do not take these products at the same time.
Alka-Seltzer Plus® Maximum Strength Cough, Mucus & Congestion Day PowerMax® Gels
Alka-Seltzer Plus® Maximum Strength Cough, Mucus & Congestion Night PowerMax® Gels
Active Ingredients And Purpose
Active ingredients (in each capsule) Purposes
Acetaminophen 325 mg…………….……….Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg…………..Cough suppressant
Guaifenesin 200 mg…………………………………………..Expectorant
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
Uses
Uses
· helps loosen phlegm (mucus) and thin bronchial secretions to rid
the bronchial passageways of bothersome mucus and make coughs
more productive
· temporarily relieves these symptoms due to a cold or flu:
· nasal congestion · sinus congestion and pressure
· minor aches and pains · headache
· cough · sore throat
· 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.
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
Ask A Doctor Before Use If You Have
Ask a doctor before use if you have
● liver disease ● heart disease ● high blood pressure
● thyroid disease ● diabetes
● difficulty in urination due to enlargement of the prostate gland
● persistent or chronic cough such as occurs with smoking, asthma,
chronic bronchitis or emphysema
● cough with excessive phlegm (mucus)
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
Ask A Doctor Or Pharmacist Before Use If You Are
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you are
● taking the blood thinning drug warfarin
● taking sedatives or tranquilizers
When Using This Product
When using this productdo 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
Stop Use And Ask A Doctor If
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 fever, 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
If Pregnant 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.
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.
Directions
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 the last Night dose before starting Day product
· adults and children 12 years and over: take 2 capsules with water
every 4 hours. Do not exceed 6 capsules in 12 hours or as
directed by a doctor.
· children under 12 years: do not use
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 the last Day dose before starting Night product
· adults and children 12 years and over: take 2 capsules with water
every 4 hours. Do not exceed 4 capsules in 12 hours or as
directed by a doctor.
· children under 12 years: do not use
Other Information
Other information
· store at 15°- 25°C (59° - 77°F)
Other information
· store at 15° - 25°C (59° - 77°F)
Inactive Ingredients
Inactive ingredients FD&C red No. 40, gelatin, glycerin, lecithin, medium chain triglycerides, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide
Inactive ingredients D&C yellow No. 10, FD&C blue No. 1, gelatin, glycerin, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide
Questions Or Comments
Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)
Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)
Product Carton Label 24 Count
NEW
Alka-Seltzer
PLUS
MAXIMUM
STRENGTH
Cough,
Mucus &
Congestion
POWERMAX® GELS
CONCENTRATED FORMULA
DAY NON DROWSY
ACETAMINOPHEN / Pain Reliever-Fever Reducer
Dextromethorphan HBr / Cough Suppressant
Guaifenesin / Expectorant
Phenylephrine HCl / Nasal Decongestant
- Nasal/Chest Congestion
- Headache, Body Ache Sore Thoat, Fever
- Cough
- Mucus
- Nasal / Chest Congestion
- Headache, Body Ache, Sore Throat, Fever
- Runny Nose, Sneezing
- Cough
16 LIQUID GELS
NIGHT
ACETAMINOPHEN / Pain Reliever-Fever Reducer
Dextromethorphan HBr / Cough Suppressant
Doxylamine Succinate / Antihistamine
Phenylephrine HCl / Nasal Decongestant
8 LIQUID GELS: 24 TOTAL
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