OTC Medication Information: ACETAMINOPHEN 325 MG
ACETAMINOPHEN 325 MG- acetaminophen tablet
Reliable 1 Laboratories LLC
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.
Drug Facts
Active ingredient (in each tablet)
Acetaminophen USP, 325 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- the common cold
- toothache
- premenstrual or menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg in 24 hours, which is the maximum daily amount
- child takes more than 5 tablets in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
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.
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
- 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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
adults and children 12 years and over | take 2 tablets every 4-6 hours while symptoms last, not more than 12 tablets in 24 hours |
children 6 to 11 years | take 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours |
children under 6 years | do not use |
Other information
- store at 15° to 30°C (59° to 86°F)
Inactive ingredients
povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid
Questions or comments?
call 516-341-0666, 8:30 am — 4:30 pm ET, Monday — Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol®.
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
www.reliable1labs.com
NDC 69618-010-01
Regular Strength
Acetaminophen USP 325 mg
PAIN RELIEVER
FEVER REDUCER
100 TABLETS
*Compare to Active Ingredient in Regular Strength TYLENOL®
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Labeler — Reliable 1 Laboratories LLC (079718111) |
Registrant — Reliable 1 Laboratories LLC (079718111) |
Revised: 03/2023 Reliable 1 Laboratories LLC
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.
https://otclabels.com/lib/otc/otc-meds/acetaminophen-325-mg-3/