Pain and Fever by RUGBY LABORATORIES
Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: RUGBY LABORATORIES
NDC Code: 0536-3222
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Active ingredient (in each tablet)
Acetaminophen 325 mg
Pain reliever/fever reducer
- for the temporary relief of minor aches and pains due to:
- muscular aches
- minor pain of arthritis
- the common cold
- premenstrual and menstrual cramps
- temporarily reduces fever
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
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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if the user has liver disease
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
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.
If pregnant or breast-feeding,ask a health professional before use.
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.
do not take more than directed (see overdose warning)
|adults and children 12 years and over||
|children 6 years to under 12 years||
|children under 6 years||ask a doctor|
Other information store at room temperature
Inactive ingredients povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid
Questions or comments? 1-800-645-2158
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
|PAIN AND FEVER
|Labeler - RUGBY LABORATORIES (079246066)|
|Registrant - Gemini Pharmaceuticals, Inc. (055942270)|
|Gemini Pharmaceuticals, Inc.||055942270||manufacture(0536-3222)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.