TYLENOL PM- acetaminophen, diphenhydramine hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

Navajo Manufacturing Company Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 500 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Authorization status:

OTC monograph not final

Summary of Product characteristics

TYLENOL PM- ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM
COATED
NAVAJO MANUFACTURING COMPANY INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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TYLENOL PM
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
_PURPOSE_
Pain reliever/fever reducer
_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 g