1. Home
  2. Labeler Index
  3. Savings Distributors Llc
  4. 73097-013
  5. Label Information: Tylenol Pm

FDA Label for Tylenol Pm

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CAPLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PACKAGE LABELING

Tylenol Pm Product Label

The following document was submitted to the FDA by the labeler of this product Savings Distributors Llc. 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.

Active Ingredients (In Each Caplet)



Acetaminophen 500 mg

Diphenhydramine HCl 25 mg


Purpose



Pain reliever

Nighttime sleep aid


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
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.
■ with any other 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: 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.


Other Information



■ store between 20-25°C (68-77°F)
■ do not use if pouch is torn or damaged


Inactive Ingredients



carnauba wax, crospovidone, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide


Questions Or Comments?



call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)


Package Labeling



Package Label - TylenolPM 25

Package Label - TylenolPM 25


* Please review the disclaimer below.