Acetaminophen USP 325 mg Tablets
SPL UNCLASSIFIED SECTION
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
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
OTHER SAFETY INFORMATION
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
- skin reddening
- blisters
- rash
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.
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
These could be signs of a serious condition.
- 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
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: 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
| 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 |
- do not take more than directed (see overdose warning)
Other information
- store at 15° to 30°C (59° to 86°F)
Inactive ingredients
povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
SPL UNCLASSIFIED SECTION
*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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 69618-010-01
Regular Strength
Acetaminophen USP 325 mg
PAIN RELIEVER
FEVER REDUCER
100 TABLETS
*Compare to Active Ingredient in Regular Strength TYLENOL®