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Allergy plus Sinus Headache (allergy plus sinus headache (acetaminophen 325 mg, diphenhydramine hcl 12.5 mg, phenylephrine hcl 5 mg) tablet, film coated) Dailymed

  1. Human OTC
    • Drug Classes
  3. Shield Pharmaceuticals Corp

Generic: acetaminophen 325 mg, diphenhydramine hcl 12.5 mg, phenylephrine hcl 5 mg

Allergy plus Sinus Headache tablet, film coated - (allergy plus sinus headache (acetaminophen 325 mg, diphenhydramine hcl 12.5 mg, phenylephrine hcl 5 mg) tablet, film coated) image

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    COLOR: green

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Drug Facts

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 
  • bulers 
  • 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 Section


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

Otc - Keep Out Of Reach Of Children Section


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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)


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.

Inactive Ingredients


croscarmellose sodium, colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, starch, talc, titanium dioxide

Questions Or Comments?


1-800-373-6981 (toll-free)


Shield Pharmaceuticals Corp. Hauppauge, NY 11788

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

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DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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