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Generic: acetaminophen


IMPRINT: GPI A5     SHAPE: round
    COLOR: white    SCORE: 2

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acetaminophen 500 mg - gpi a5 round white

apap 500 mg oral tablet - gpi a5 round white

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Drug Facts

Otc - Active Ingredient Section


Active ingredient (in each tablet)

Acetaminophen 500 mg

Otc - Purpose Section


Purposes

Pain reliever/fever reducer

Indications & Usage Section


Uses temporarily reduces fever and relieves minor aches and pains caused by
  • headache
  • muscular aches
  • common cold
  • toothache
  • premenstrual and menstrual cramps
  • backache
  • minor pain of arthritis

Warnings Section


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

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 allergic to acetaminophen or any of the inactive ingredients in this product

OTC - ASK DOCTOR SECTION


Ask a doctor before use if you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION


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

OTC - STOP USE SECTION


Stop use and ask a doctor if
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present These could be signs of a serious condition.

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 take more than directed (see Overdose warning)

​ adults and children 12 years and over:
  • take 2 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets in 24 hours unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

Storage And Handling Section


Other information store at room temperature

Inactive Ingredient Section


Inactive ingredients Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Otc - Questions Section


Questions or comments? call 1-800-645-2158

Other Safety Information


TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


Distributed By: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

www.rugbylaboratories.com

Package Label.principal Display Panel


Rugby®

NDC 0536-3231-01

See New Warnings Information & Directions

EXTRA STRENGTH Pain & Fever

Acetaminophen 500 mg Each

100 TABLETS



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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