Complete SPL Sections#
SPL PATIENT PACKAGE INSERT SECTION
SPL PATIENT PACKAGE INSERT SECTION
Do not take these products at the same time.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Drug Facts
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Alka-Seltzer Plus® Maximum Strength Day Cold & Flu PowerMax™ Gels
OTC - ACTIVE INGREDIENT SECTION
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each capsule) Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg
OTC - PURPOSE SECTION
OTC - PURPOSE SECTION
Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant
Uses
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 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
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
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 - ASK DOCTOR/PHARMACIST SECTION
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfa
OTC - WHEN USING SECTION
OTC - WHEN USING SECTION
When using this product do not exceed recommended dosage
OTC - STOP USE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
IIf pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
INDICATIONS & USAGE 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 information
OTHER SAFETY INFORMATION
Other information ● store at room temperature. Avoid temperatures above 25°C (77°F).
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENT SECTION
Inactive ingredients FD&C yellow #6, ferric oxide, gelatin, glycerin, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide
Questions or comments?
OTC - QUESTIONS SECTION
Questions or comments? 1-800-986-0369 (Mon-Fri 9AM -5PM EST)
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Alka-Seltzer Plus® Maximum Strength Night Cold & Flu PowerMax™ Gels
OTC - ACTIVE INGREDIENT SECTION
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each capsule) Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Doxylamine succinate 6.25 mg Phenylephrine hydrochloride 5 mg
OTC - PURPOSE SECTION
OTC - PURPOSE SECTION
Purposes Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Uses
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 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
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
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
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 - WHEN USING SECTION
OTC - WHEN USING SECTION
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 - WHEN USING SECTION
OTC - WHEN USING 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
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
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
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 information
OTHER SAFETY INFORMATION
Other information ● store at room temperature. Avoid temperatures above 25°C (77°F).
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENT SECTION
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?
OTC - QUESTIONS SECTION
Questions or comments? 1-800-986-0369 (Mon-Fri 9AM -5PM EST)
