FDA Label for Maximum Strength Non Drowsy Day And Night Cold And Flu

Spl Patient Package Insert

Do not take these products at the same time.

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.