Pain and Fever (acetaminophen 500 mg) Dailymed
Generic: acetaminophen
IMPRINT: GPI A5
SHAPE: oval
COLOR: white
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Drug Facts
Otc - Active Ingredient Section
Active ingredient (in each captab)
Acetaminophen 500 mg
Otc - Purpose Section
Purpose
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
- backache
- premenstrual and menstrual cramps
- 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 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
- redness or swelling is present
- fever gets worse or lasts more than 3 days
- new symptoms appear
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 captabs every 6 hours while symptoms last
- do not take more than 6 captabs 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 hypromellose, polyethylene glycol, povidone, pregelatinized corn 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
www.rugbylaboratories.com
Package Label.principal Display Panel
Rugby® NDC 0536-3218-01 EXTRA STRENGTH Pain & Fever
Acetaminophen 500 mg each 100 CAPTABS![]()
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."
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"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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