Tylenol PM
McNeil Consumer Healthcare Div McNeil-PPC, Inc
TYLENOL PM Caplets
FULL PRESCRIBING INFORMATION: CONTENTS*
- Tylenol PM Uses
- Warnings
- Directions
- Tylenol PM Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
FULL PRESCRIBING INFORMATION
Drug Facts
Active ingredient
Purpose
| Active ingredients (in each caplet) | Purpose |
| Acetaminophen 500 mg | Pain reliever |
| Diphenhydramine HCl 25 mg | Nighttime sleep aid |
Tylenol PM Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 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.
- with any product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
- pain gets worse or lasts more than 10 days
- 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.
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. (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)
| adults and children 12 years and over |
|
| children under 12 years | do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage |
Tylenol PM Other information
- store between 20-25°C (68-77°F)
- do not use is carton is opened, or neck wrap or foil inner seal imprinted "Safety Seal®" is broken or missing
- see end panel for lot number and expiration date
Inactive ingredients
carnauba wax, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium citrate, sodium starch glycolate, titanium dioxide
Questions or comments?
call 1-877-895-3665
PRINCIPAL DISPLAY PANEL
See New Warnings Information & Directions
NDC 50580-482-10
Extra Strength
TYLENOL®
PM
Caplets
Pain Reliever
Nighttime Sleep Aid
Acetaminophen,
Diphenhydramine HCl
100 CAPLETS
Non-habit
forming
Tylenol PMAcetaminophen and Diphenhydramine Hydrochloride TABLET, FILM COATED
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