Tylenol PM — v3

Tylenol PM

5 Views

Version

v3

Effective date

November 8, 2023

Original packager

Sections captured

18

Identifiers

Document ID
09af5277-5a19-3c72-e063-6294a90a704d
Set ID
83df6b68-8bb5-410b-bb97-0a5eecf424f2
Application numbers
M013
Product NDCs
50269-608
Package NDCs
50269-608-06
Original packager NDCs
50580-608

Names & Manufacturers

Brand names
Tylenol PM
Generic names
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer names
JC World Bell Wholesale Co., Inc.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
1092189, 1092378
UNII
362O9ITL9D, TC2D6JAD40
UPC
0852682507670

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg Purpose Pain reliever Nighttime sleep aid
Ask Doctor (1)

Sequence 1

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 Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers
Do Not Use (1)

Sequence 1

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
Dosage And Administration (1)

Sequence 1

Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets at bedtime do not take more than 2 caplets of this product in 24 hours Children under 12 years do not use
Dosage And Administration Table (1)

Sequence 1

adults and children 12 years and overtake 2 caplets at bedtimedo not take more than 2 caplets of this product in 24 hours
Children under 12 years do not use
Inactive Ingredient (1)

Sequence 1

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
Indications And Usage (1)

Sequence 1

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. 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. Overdose warning:
Package Label Principal Display Panel (1)

Sequence 1

Package Labeling: Label
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Pain reliever Nighttime sleep aid
Questions (1)

Sequence 1

Questions or comments? call (toll-free) or (collect) 1-877-895-3665 215-273-8755
Spl Product Data Elements (1)

Sequence 1

Tylenol PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE CARNAUBA WAX CROSPOVIDONE FD&C BLUE NO. 1 ALUMINUM OXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 POVIDONE, UNSPECIFIED STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE TY;PM
Spl Unclassified Section (2)

Sequence 1

Drug Facts

Sequence 2

Other information store between 20-25°C (68-77°F) do not use if pouch is torn or damaged
Stop Use (1)

Sequence 1

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.
Warnings (1)

Sequence 1

Warnings This product contains acetaminophen. Severe liver damage may occur if you take Liver warning: acetaminophen may cause severe skin reactions. Symptoms may include: Allergy alert: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. 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 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. 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. Overdose warning:
When Using (1)

Sequence 1

When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery

OpenFDA raw payload

{'application_number': ['M013'],
 'brand_name': ['Tylenol PM'],
 'generic_name': ['ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE'],
 'manufacturer_name': ['JC World Bell Wholesale Co., Inc.'],
 'original_packager_product_ndc': ['50580-608'],
 'package_ndc': ['50269-608-06'],
 'product_ndc': ['50269-608'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['1092189', '1092378'],
 'spl_id': ['09af5277-5a19-3c72-e063-6294a90a704d'],
 'spl_set_id': ['83df6b68-8bb5-410b-bb97-0a5eecf424f2'],
 'substance_name': ['ACETAMINOPHEN', 'DIPHENHYDRAMINE HYDROCHLORIDE'],
 'unii': ['362O9ITL9D', 'TC2D6JAD40'],
 'upc': ['0852682507670']}