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  5. Label Information: Cold And Flu Severe Daytime

FDA Label for Cold And Flu Severe Daytime

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING
    5. ALLERGY ALERT
    6. SORE THROAT WARNING
    7. DO NOT USE
    8. ASK A DOCTOR BEFORE USE IF YOU HAVE
    9. OTC - ASK DOCTOR/PHARMACIST
    10. OTC - WHEN USING
    11. STOP USE AND ASK A DOCTOR IF
    12. OTC - PREGNANCY OR BREAST FEEDING
    13. OTC - KEEP OUT OF REACH OF CHILDREN
    14. OVERDOSE WARNING
    15. DIRECTIONS
    16. OTHER INFORMATION
    17. INACTIVE INGREDIENTS
    18. QUESTIONS?
    19. PRINCIPAL DISPLAY PANEL - 24 SOFTGEL BLISTER PACK CARTON

Cold And Flu Severe Daytime Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. 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.

Other



Drug Facts


Otc - Purpose



Active ingredients (in each softgel)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses



  • temporarily relieves common cold/flu symptoms:
    • nasal congestion
    • sinus congestion & pressure
    • cough due to minor throat & bronchial irritation
    • minor aches & pains
    • headache
    • fever
    • sore throat
    • reduces swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Liver Warning



This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 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

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.


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



  • 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.

Ask A Doctor Before Use If You Have



  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to enlarged prostate gland
  • a sodium-restricted diet
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - Ask Doctor/Pharmacist



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 use more than directed.


Stop Use And Ask A Doctor If



  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, or cough 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.


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdose Warning



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • take only as directed
  • do not exceed 8 softgels per 24 hrs
    • adults & children 12 yrs & over2 softgels with water every 4 hours
    children 4 to under 12 yrsask a doctor
    children under 4 yrsdo not use

Other Information



  • store at 20-25°C (68-77°F)
  • protect from light, heat and moisture

Inactive Ingredients



FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide


Questions?



Call toll free: 1-888-423-0139


Principal Display Panel - 24 Softgel Blister Pack Carton



NDC: 36800-826-24

*Compare to the active ingredients
in Vicks® Dayquil™ Severe Cold & Flu

MULTI-SYMPTOM RELIEF

Day Time
Cold & Flu Relief
SEVERE

PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN
COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
EXPECTORANT - GUAIFENESIN
NASAL DECONGESTANT - PHENYLEPHRINE HCl

• Headache, Fever, Sore Throat, Minor Aches & Pains
• Sinus Congestion & Pressure
• Nasal Congestion • Cough

Alcohol Free
Antihistamine Free
Non-Drowsy

24 SOFTGELS

actual size

PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton - topcare 01

PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton - topcare 01


* Please review the disclaimer below.