Pain and Fever (acetaminophen 325 mg) Dailymed
Generic: acetaminophen
IMPRINT: GPIA325
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COLOR: white
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Drug Facts
Otc - Active Ingredient Section
Active ingredient (in each tablet)
Acetaminophen 325 mg
Otc - Purpose Section
Purposes
Pain reliever/fever reducer
Indications & Usage Section
Uses
- for the temporary relief of minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- the common cold
- toothache
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings Section
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 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 the user has liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the user is 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 in adults
- pain gets worse or lasts more than 5 days in children under 12 years
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt 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 4 to 6 hours while symptoms last
- do not take more than 10 tablets in 24 hours. unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years
- take 1 tablet every 4 to 6 hours while symptoms last
- do not take more than 5 tablets in 24 hours
- do not use for more than 5 days unless directed by a doctor
children under 6 years ask a doctor
Storage And Handling Section
Other information store at room temperature
Inactive Ingredient Section
Inactive ingredients povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid
Otc - Questions Section
Questions or comments? 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 0536-3222-01 REGULAR STRENGTH Pain & Fever
Acetaminophen 325 mg Each
See New Warnings Information & Directions
100 TABLETS
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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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