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  5. Label Information: Equate Health Non Drowsy Day Cold And Flu Plus And Nighttime Cold And Flu Plus

FDA Label for Equate Health Non Drowsy Day Cold And Flu Plus And Nighttime Cold And Flu Plus

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH SOFTGEL)
    2. PURPOSES
    3. USES
    4. OTHER
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Equate Health Non Drowsy Day Cold And Flu Plus And Nighttime Cold And Flu Plus Product Label

The following document was submitted to the FDA by the labeler of this product Wal-mart Stores Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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


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


Other



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.


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

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

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

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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


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

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 Plus and NIGHTTIME Cold & Flu Plus 20ct

Compare to the active ingredients in

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

NON-DROWSY DAY

Cold & Flu Plus

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 Plus

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


* Please review the disclaimer below.