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  5. Label Information: Allergy Plus Sinus Headache

FDA Label for Allergy Plus Sinus Headache

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH LIQUID-FILLED CAPSULE)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Allergy Plus Sinus Headache Product Label

The following document was submitted to the FDA by the labeler of this product Shield Pharmaceuticals Corp. 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

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Shield Pharmaceuticals Corp.
Hauppauge, NY 11788


Active Ingredient (In Each Liquid-Filled Capsule)



Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg


Purpose



Pain reliever

Antihistamine

Nasal decongestant


Uses



  • temporarily relieves these symptoms of hay fever and the common cold:
  • runny nose
  • sneezing
  • headache
  • minor aches and pains
  • nasal congestion
  • temporarily relieves these additional symptoms of hay fever:
  • itching of the nose or throat
  • itchy, watery eyes

Warnings



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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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 
    • hives
    • facial swelling 
    • asthma (wheezing) 
    • shock

      • If a skin reaction occurs, stop use and seek medical help right away.


      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.
      • with any other product containing diphenhydramine, even one used on skin
      • 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 acetaminophen, ask a doctor or pharmacist.

Ask A Doctor Before Use If You Have



  • liver disease
  • glaucoma 
  • thyroid disease 
  • heart disease
  • diabetes 
  • high blood pressure 
  • difficulty in urination due to enlargement of the prostate gland 
  • a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are



  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When Using This Product



  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery 
  • avoid alcoholic beverages

Stop Use And Ask A Doctor If



  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

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.1(800)222-1222


Directions



  • do not use more than directed
  • adults and children 12 years and over: take 2 caplets every 4 hours
  • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

Other Information



  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients



corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, talc, titanium dioxide


Questions Or Comments?



1-800-373-6981 (toll-free)


Principal Display Panel



Allergy plus
Sinus headache
Acetaminophen


Diphenhydramine HCl
Phenylephrine HCl
Pain reliever / Antihistamine /


Relieves:
runny nose • sneezing • headache
• minor aches and pains • hay fever
• nasal congestion • itching of the nose or throat
• itchy, watery eyes

Labe

Carton


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