Pain Relief PM Extra Strength — v6

Pain Relief PM Extra Strength

8 Views

Version

v6

Effective date

October 11, 2024

Original packager

Yes

Sections captured

20

Identifiers

Document ID
2435717d-bbb9-9e00-e063-6394a90a75ad
Set ID
475becec-1a56-4cfa-a0c5-562f8772adfb
Application numbers
M013
Product NDCs
63868-325
Package NDCs
63868-325-01, 63868-325-50
Original packager NDCs

Names & Manufacturers

Brand names
Pain Relief PM Extra Strength
Generic names
ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer names
Chain Drug Marketing Association
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
UNII
362O9ITL9D, TC2D6JAD40
UPC
0635515995970

Structured Label Sections

Active Ingredient (1)

Sequence 1

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

Sequence 1

Active ingredients (in each caplet) Purpose
Acetaminophen 500 mgPain reliever
Diphenhydramine HCl 25 mgNighttime 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
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 yearsdo 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
Inactive Ingredient (1)

Sequence 1

Inactive ingredients colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, 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.
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL NDC 63868-325-50 QUALITY CHOICE †Compare to Extra Strength TYLENOL® PM active ingredients Extra Strength Pain Relief PM Pain Reliever, Nighttime Sleep Aid Acetaminophen, Diphenhydramine HCl 50 Caplets 50 count
Pregnancy Or Breast Feeding (1)

Sequence 1

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

Sequence 1

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

Sequence 1

Active ingredients (in each caplet) Purpose
Acetaminophen 500 mgPain reliever
Diphenhydramine HCl 25 mgNighttime sleep aid
Spl Product Data Elements (1)

Sequence 1

Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride SILICON DIOXIDE COPOVIDONE K25-31 CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 HYPROMELLOSE, UNSPECIFIED LACTOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE AAA;1031
Spl Unclassified Section (1)

Sequence 1

Drug Facts
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.
Storage And Handling (1)

Sequence 1

Other information store between 20-25°C (68-77°F) in a dry place retain carton for complete product information
Warnings (1)

Sequence 1

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 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.
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': ['Pain Relief PM Extra Strength'],
 'generic_name': ['ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Chain Drug Marketing Association'],
 'package_ndc': ['63868-325-50', '63868-325-01'],
 'product_ndc': ['63868-325'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['1092189'],
 'spl_id': ['2435717d-bbb9-9e00-e063-6394a90a75ad'],
 'spl_set_id': ['475becec-1a56-4cfa-a0c5-562f8772adfb'],
 'substance_name': ['ACETAMINOPHEN', 'DIPHENHYDRAMINE HYDROCHLORIDE'],
 'unii': ['362O9ITL9D', 'TC2D6JAD40'],
 'upc': ['0635515995970']}