Equate Non Drowsy Day Cold And Flu Formula And Nighttime Cold And Flu Formula

Equate Non Drowsy Day Cold And Flu Formula And Nighttime Cold And Flu Formula
SPL v8
SPL
SPL Set ID 547ff880-3d40-4a4a-84ee-cd0d5290a9b9
Route
ORAL
Published
Effective Date 2022-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol 400 Povidone Propylene Glycol Sorbitol Fd&c Red No. 40 Titanium Dioxide D&c Yellow No. 10 Fd&c Blue No. 1 Sorbitan Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Imprint: 116;A07 Shape: oval Color: red Color: green Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-11

Description

Equate Health COLD & FLU FORMULA DAY NON-DROWSY Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg Equate Health COLD & FLU FORMULA NIGHT Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg

Purpose

DAY COLD & FLU FORMULA Pain reliever/fever reducer Cough suppressant Nasal decongestant NIGHT COLD & FLU FORMULA Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant


Medication Information

Purpose

DAY COLD & FLU FORMULA Pain reliever/fever reducer Cough suppressant Nasal decongestant NIGHT COLD & FLU FORMULA Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Description

Equate Health COLD & FLU FORMULA DAY NON-DROWSY Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg Equate Health COLD & FLU FORMULA NIGHT Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg

Uses

DAY COLD & FLU FORMULA

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

NIGHT COLD & FLU FORMULA

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Section 50565-1

If pregnant or breast-feeding, ask a health professional before use.

Section 50568-5

DAYTIME COLD & FLU FORMULA

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

NIGHTTIME COLD & FLU FORMULA

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Purposes

DAY COLD & FLU FORMULA

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

NIGHT COLD & FLU FORMULA

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Undefined

Liver warning

DAY COLD & FLU FORMULA

These products contain acetaminophen. Severe liver damage may occur if you take

  • more than 10 softgels in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product



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.

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

NIGHTTIME COLD & FLU FORMULA

Liver warning

These products contain acetaminophen. Severe liver damage may occur if you take

  • more than 10 softgels in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use to sedate children.

Directions

DAY COLD & FLU FORMULA

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

NIGHTTIME COLD & FLU FORMULA

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
  • children under 12 years: do not use
Do Not Use

DAY COLD & FLU FORMULA

  • 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

NIGHTTIME COLD & FLU FORMULA

  • 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
Other Information
  • store at room temperature. Avoid excessive heat.
Inactive Ingredients

DAY COLD & FLU FORMULA

FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

NIGHTTIME COLD & FLU FORMULA

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene, glycol-400, povidone, propylene glycol, purified water, shellac, sorbitol

sorbitan, sodium hydroxide, titanium dioxide

Questions Or Comments?

1-888-287-1915

Principal Display Panel

Equate NON-DROWSY DAY Cold & Flu Formula and NIGHTTIME Cold & Flu Formula 20ct



Compare to the active ingredients in

Alka-Seltzer PLUS® Day and Night Cold and Flu Formula*



NON-DROWSY DAY

Cold & Flu Formula

ACETAMINOPHEN- Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr - Cough suppressant

PHENYLEPHRINE HCI - Nasal decongestant

Relieves:

Nasal congestion; Cough;

Headache & body ache;

Sore throat; Sinus pressure

12 SOFTGELS



NIGHTTIME

Cold & Flu Formula

ACETAMINOPHEN- Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr - Cough suppressant

DOXYLAMINE SUCCINATE - Antihistamine

PHENYLEPHRINE HCI - Nasal decongestant

Relieves:

Nasal congestion; Cough;

Headache & body ache;

Sore throat; Runny nose

8 SOFTGELS

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND

TAMPER-EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT

*This product is not manufactured or distributed by Bayer

Healthcare LLC, owner of the registered trademark

Alka-Seltzer PLUS® Day and Night Cold and Flu Formula

When Using This Product

DAYTIME COLD & FLU FORMULA

When using this product do not exceed recommended dosage

NIGHTTIME COLD & FLU FORMULA

  • 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

DAYTIME COLD & FLU FORMULA

  • 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

NIGHTTIME COLD &FLU  FORMULA

  • 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
Ask A Doctor Before Use If You Have

DAYTIME COLD & FLU FORMULA

  • 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

NIGHTTIME COLD & FLU FORMULA

  • 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
Active Ingredients (in Each Softgel)

Equate Health COLD & FLU FORMULA DAY NON-DROWSY

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Equate Health COLD & FLU FORMULA NIGHT

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg


Structured Label Content

Uses

DAY COLD & FLU FORMULA

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

NIGHT COLD & FLU FORMULA

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Section 50565-1 (50565-1)

If pregnant or breast-feeding, ask a health professional before use.

Section 50568-5 (50568-5)

DAYTIME COLD & FLU FORMULA

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

NIGHTTIME COLD & FLU FORMULA

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purposes

DAY COLD & FLU FORMULA

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

NIGHT COLD & FLU FORMULA

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Undefined (undefined)

Liver warning

DAY COLD & FLU FORMULA

These products contain acetaminophen. Severe liver damage may occur if you take

  • more than 10 softgels in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product



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.

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

NIGHTTIME COLD & FLU FORMULA

Liver warning

These products contain acetaminophen. Severe liver damage may occur if you take

  • more than 10 softgels in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use to sedate children.

Directions

DAY COLD & FLU FORMULA

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

NIGHTTIME COLD & FLU FORMULA

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
  • children under 12 years: do not use
Do Not Use (Do not use)

DAY COLD & FLU FORMULA

  • 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

NIGHTTIME COLD & FLU FORMULA

  • 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
Other Information (Other information)
  • store at room temperature. Avoid excessive heat.
Inactive Ingredients (Inactive ingredients)

DAY COLD & FLU FORMULA

FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

NIGHTTIME COLD & FLU FORMULA

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene, glycol-400, povidone, propylene glycol, purified water, shellac, sorbitol

sorbitan, sodium hydroxide, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-287-1915

Principal Display Panel

Equate NON-DROWSY DAY Cold & Flu Formula and NIGHTTIME Cold & Flu Formula 20ct



Compare to the active ingredients in

Alka-Seltzer PLUS® Day and Night Cold and Flu Formula*



NON-DROWSY DAY

Cold & Flu Formula

ACETAMINOPHEN- Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr - Cough suppressant

PHENYLEPHRINE HCI - Nasal decongestant

Relieves:

Nasal congestion; Cough;

Headache & body ache;

Sore throat; Sinus pressure

12 SOFTGELS



NIGHTTIME

Cold & Flu Formula

ACETAMINOPHEN- Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr - Cough suppressant

DOXYLAMINE SUCCINATE - Antihistamine

PHENYLEPHRINE HCI - Nasal decongestant

Relieves:

Nasal congestion; Cough;

Headache & body ache;

Sore throat; Runny nose

8 SOFTGELS

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND

TAMPER-EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT

*This product is not manufactured or distributed by Bayer

Healthcare LLC, owner of the registered trademark

Alka-Seltzer PLUS® Day and Night Cold and Flu Formula

When Using This Product (When using this product)

DAYTIME COLD & FLU FORMULA

When using this product do not exceed recommended dosage

NIGHTTIME COLD & FLU FORMULA

  • 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)

DAYTIME COLD & FLU FORMULA

  • 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

NIGHTTIME COLD &FLU  FORMULA

  • 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
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

DAYTIME COLD & FLU FORMULA

  • 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

NIGHTTIME COLD & FLU FORMULA

  • 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
Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Equate Health COLD & FLU FORMULA DAY NON-DROWSY

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Equate Health COLD & FLU FORMULA NIGHT

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg


Advanced Ingredient Data


Raw Label Data

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