Non Drowsy Day And Night Multi-symptom Cold And Flu Formula

Non Drowsy Day And Night Multi-symptom Cold And Flu Formula
SPL v4
SPL
SPL Set ID 3ee916f1-6c59-4233-ae56-1af41087bb56
Route
ORAL
Published
Effective Date 2023-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol 400 Povidone Propylene Glycol Sorbitol 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 2023-04-06
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 42229-5

Distributed by:

MIDWOOD BRANDS, LLC

500 Volvo Pkwy

Chesapeake, VA 23320 USA

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

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 42229-5 (42229-5)

Distributed by:

MIDWOOD BRANDS, LLC

500 Volvo Pkwy

Chesapeake, VA 23320 USA

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

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:57.682228 · Updated: 2026-03-14T23:06:08.994677