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  5. Label Information: Dayquil Severe Plus Vicks Vapocool Cold And Flu

FDA Label for Dayquil Severe Plus Vicks Vapocool Cold And Flu

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING
    5. ALLERGY ALLERT
    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. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS?
    18. PRINCIPAL DISPLAY PANEL - 2 CAPLET POUCH BLISTER PACK

Dayquil Severe Plus Vicks Vapocool Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Select Corporation. 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

PRODUCT REPACKAGED AND DISTRIBUTED WITH PERMISSION OF
MANUFACTURER BY:
SELECT CORPORATION 1433 WAINWRIGHT WAY CARROLLTON, TX 75007


Otc - Purpose



Active ingredients (in each caplet)Purpose
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 caplets in 24 hrs, 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 Allert



Acetaminophen may cause severe skin reactions. Symptoms nay 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
  • trouble urinating due to enlarged prostate gland
  • 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.


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 get 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. 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



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

Other Information



  • each caplet contains: sodium 4 mg
  • do not exceed 25°C

Inactive Ingredients



croscarmellose sodium, crospovidone, FD&C Yellow No. 6 Aluminum Lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide


Questions?



1-800-362-1683


Principal Display Panel - 2 Caplet Pouch Blister Pack



DayQuil™
SEVERE+

VICKS®
VapoCOOL™

COLD & FLU

Acetaminophen, Phenylephrine HCl,
Dextromethorphan HBr, Guaifenesin

* Please review the disclaimer below.