FDA Label for Acetaminophen 325 Mg
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- OTHER SAFETY INFORMATION
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- HOW SUPPLIED
Acetaminophen 325 Mg Product Label
The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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
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
Other Safety Information
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.
Otc - Do Not Use
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
Ask a doctor before use if the user has liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
How Supplied
Product: 50090-5459
NDC: 50090-5459-4 20 TABLET in a BOTTLE
* Please review the disclaimer below.