Alka-Seltzer Plus Maximum Strength Day and Light Cold and Flu Liquid gels (project Fortify)
SPL UNCLASSIFIED SECTION
Drug Facts
SPL UNCLASSIFIED SECTION
Alka-Seltzer Plus
Maximum Strength Day & Night Cold & Flu Liquid Gels
OTC - ACTIVE INGREDIENT SECTION
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
INDICATIONS & USAGE SECTION
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
WARNINGS SECTION
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.
OTC - DO NOT USE SECTION
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 SECTION
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
OTC - WHEN USING SECTION
When using this product do not exceed recommended dosage.
OTC - STOP USE SECTION
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 SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 SECTION
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 SECTION
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
OTC - QUESTIONS SECTION
Questions or comments? 1-800-986-0369 (Mon-Fri 9AM -5PM EST)
SPL UNCLASSIFIED SECTION
Alka-Seltzer Plus® Maximum Strength Night Cold & Flu Liquid Gels
OTC - ACTIVE INGREDIENT SECTION
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 SECTION
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 SECTION
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 SECTION
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 SECTION
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 SECTION
Ask a doctor or pharmacist before use if you are
● taking the blood thinning drug warfarin
● taking sedatives or tranquilizers
OTC - STOP USE SECTION
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 SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
Other information
Other information
● store at room temperature. Avoid excessive heat above 40°C
(104°F).
INACTIVE INGREDIENT SECTION
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 SECTION
Questions or comments? 1-800-986-0369 (Mon-Fri 9AM -5PM EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Alka-Seltzer Plus®
DAY NON-DROWSY
ACETAMINOPHEN / Pain Reliever-Fever Reducer
Dextromethorphan HBr / Cough Suppresant
Phenylephrine HCl / Nasal Decongestant
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)
- Nasal Congestion
- Headache & Body Ache
- Cough
- Sore Throat
- Sinus Congestion