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  5. Label Information: Dover Sudanyl Pe

FDA Label for Dover Sudanyl Pe

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. 205R MEDIQUE MEDI-PHENYL LABEL
    15. 205R DOVER SUDANYL LABEL

Dover Sudanyl Pe Product Label

The following document was submitted to the FDA by the labeler of this product Unifirst First Aid 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

Adults and children: (12 years and older) Take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age


Active Ingredient (In Each Tablet)



Phenylephrine HCl 5mg


Purpose



Nasal decongestant


Uses



Temporarily relieves

■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies

■ sinus congestion and pressure

Promotes nasal and/or sinus drainage


Otc - Do Not Use



Do not use

  • 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.

Otc - Ask Doctor



Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Otc - When Using



When using this product

■ do not exceed recommended dosage


Otc - Stop Use



Stop use and ask a doctor if

■ you get nervous, dizzy, or sleepless

■ symptoms do not improve within 7 days or are accompanied by fever


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.


Directions



  • do not use more than directed

Other Information



  • read all product information before using.
  • contains FD&C yellow #6 (tartrazine)
  • store at room temperature 59°-86° F (15°-30° C).
  • tamper evident sealed packets.
  • do not use any opened or torn packets

Inactive Ingredients



croscarmellose sodium, FD&C red #40, FD&C yellow #6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide


205R Medique Medi-Phenyl Label



Medique®
Medi-Phenyl
Pseudoephedrine Free

Pull to Open

Nasal Decongestant • Phenylephrine 5 mg
100 Tablets
(50 x 2)
Tamper Evident Unit Dose Packets


205R Dover Sudanyl Label



Dover
Sudanyl PE
Nasal and Nasal Decongestant
Non-Drowsy, Sugar Free
Phenylephrine HCl 5 mg
Dover Pharmaceutical
Products of the highest quality and effectiveness
Tamper Resistant
Sealed Packets
Unit Dose Packs
500 Tablets
(250 Packets of 2)


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