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IMPRINT: FR33     SHAPE: round
    COLOR: blue

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acetaminophen 500 mg / phenylephrine hydrochloride 5 mg oral tablet - fr33 round blue

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Drug Facts

Otc - Active Ingredient Section


Active ingredients (in each tablet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

Otc - Purpose Section


Purpose

Pain reliever/fever reducer

Nasal decongestant

Indications & Usage Section


Uses

temporarily relieves these common cold/flu symptoms:
  • nasal congestion
  • headache
  • minor aches and pains
  • stuffy nose
  • sinus congestion and pressure

temporarily reduces fever

Warnings Section


Warnings

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

â–  more than 4,000 mg of acetaminophen in 24 hours

â–  with other drugs containing acetaminophen

â–  3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

â–  skin reddening

â–  bulers

â–  rash

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

OTC - DO NOT USE SECTION


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.
  • for more than 10 days unless directed by a doctor

OTC - ASK DOCTOR SECTION


Ask a doctor before use if you have
  • liver disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • heart disease
  • trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION


Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

OTC - STOP USE SECTION


Stop use and ask a doctor if
  • you get nervous, dizzy, or sleepless
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms appear

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.

Overdose warning:

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

(1-800-222-1222).

Quick medical attention is critical for adults as well as for children even if you do not

notice any signs or symptoms.

Dosage & Administration Section


Directions
  • do not use more than directed

​ Adults and children: (12 years and older) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Ask a doctor


Other information
  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper evident sealed packets
  • do not use any opened or torn packets
  • avoid excessive heat and humidity

Inactive Ingredient Section


Inactive ingredients

corn starch, crospovidone*, FD&C blue #1*, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, pregelatinized starch*, sodium starch glycolate*, stearic acid.

*may contain

OTC - QUESTIONS SECTION


Questions or comments? 1-800-869-6970

Green Guard Advanced Sinus Relief Label


Advanced Sinus reliefâ„¢

Tabletas mejoradas para el alivio sinusal

GREEN GUARD ®

Pull to Open

Tire Para Abrir

Acetaminophen 500mg/Acetaminofeno 500 mg

Phenylephrine HCl 5mg/Fenilefrina HCl 5 mg

Pain Reliever/Fever reducer/ & Nasal Decongestant/ Alivia el dolor y reduce la fiebre y decongestivo nasal 125 Packets of 2 Tablets 250 Tablets Order #2207 Distributed by Green Guard ®, St Louis, MO 63045



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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