Spl Patient Package Insert
Do not take these products at the same time.
Maximum Strength Non Drowsy Day And Night Cold And Flu Kit
FDA Label NDC 49035-674
18 label sections · Submitted to the FDA by Wal-mart Stores Inc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Maximum Strength Non Drowsy Day And Night Cold And Flu (NDC 49035-674). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding spl patient package insert, other, otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Other
Drug Facts
Non Drowsy Day Cold & Flu
Maximum Strength Night Cold & Flu
Otc - Active Ingredient
Active ingredients (in each capsule)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
Active ingredients (in each capsule)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg
Otc - Purpose
Purposes
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Purposes
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
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 - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfa
Ask a doctor or pharmacist before use if you are
● taking the blood thinning drug warfarin
● taking sedatives or tranquilizers
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
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 - 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
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.
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
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 temperatures above 25°C (77°F).
Other information
● store at room temperature. Avoid temperatures above 25°C (77°F).
Inactive Ingredient
Inactive ingredients
FD&C yellow #6, gelatin,
glycerin, potassium aluminum silicate, polyethylene glycol, povidone,
propylene glycol, purified water, sorbitol , titanium
dioxide
Inactive ingredients FD&C Blue #1, FD&C yellow
#10, gelatin, glycerin, potassium aluminum silicate, polyethylene glycol ,
povidone, propylene glycol, purified water, sorbitol
sorbitan solution, titanium dioxide
Questions Or Comments?
Questions or comments? 1-888-333-9792
Questions or comments?1-888-287-1915
Principal Display Panel
EQUATE Maximum Strength Day & Night Cold & Flu
Compare to the active ingredients in
Alka-Seltzer PLUS® Maximum Strength Day
and Night Cold & Flu POWERMAX™ GELS
DAY NON DROWSY
Acetaminophen / Pain Reliever-Fever Reducer
Dextromethorphan HBr / Cough Suppressant
Phenylephrine HCl / Nasal Decongestant
Relieves:
Nasal Congestion
Headache & Body Ache
Cough
Sore Throat
Sinus Pressure
12 SOFTGELS
NIGHT TIME
Acetaminophen / Pain Reliever-Fever Reducer
Dextromethorphan HBr / Cough Suppressant
Doxylamine Succinate / Antihistamine
Phenylephrine HCl / Nasal Decongestant
Nasal Congestion
Headache & Body Ache
Cough
Runny Nose
Sore Throat
4 SOFTGELS
16 SOFTGELS TOTAL
*This product is not manufactured or distributed by Bayer
HealthCare LLC, owner of the registered trademark
Alka-Seltzer PLUS® POWERMAX™ GELS.
* Please review the disclaimer below.
