FDA Label for Tylenol Regular Strength
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USES
- LIVER WARNING
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Tylenol Regular Strength Product Label
The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. 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
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.
Active Ingredient (In Each Caplet)
Acetaminophen 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 and menstrual cramps
- temporarily reduces fever
Liver Warning
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (1,625 mg) in 24 hours for children. 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
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
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
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
- 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
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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)
- take 2 caplets every 4 to 6 hours while symptoms last
- do not take more than 10 caplets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
- take 1 caplet every 4 to 6 hours while symptoms last
- do not take more than 5 caplets in 24 hours
- do not use for more than 5 days unless directed by a doctor
adults and children 12 years and over | |
children 6-11 years | |
children under 6 years | ask a doctor |
Other Information
- store between 20-25°C (68-77°F)
- do not use if blister unit is torn or broken
Inactive Ingredients
carnauba wax, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide
Questions Or Comments?
Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
325mg
NDC 50580-458-11
To re-order reference the NDC Code
TYLENOL®
Acetaminophen Pain Reliever - Fever Reducer
Regular Strength
100 Caplets
325 mg each
10 Blister Cards
with
10 Individual Blisters
SMART PACKAGING
DESIGNED FOR HEALTH
CARE PROFESSIONALS
FOR HOSPITAL AND GOVERNMENT USE ONLY
* Please review the disclaimer below.