0752-major
786dbcd5-f5c2-4491-e053-2991aa0a3437
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Medication Information
Warnings and Precautions
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.
Description
Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Section 34088-5
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 42229-5
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol®.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Questions or comments?
Call (800) 616-2471
www.majorpharmaceuticals.com
Section 50565-1
Keep out of reach of children.
Section 50566-9
Stop use and ask a doctor if
■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. ■ new symptoms occur
■ redness or swelling is present
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Section 50567-7
When using this product
■ avoid alcoholic beverages
■ do not drive a motor vehicle or operate machinery
■ drowsiness will occur
Section 50568-5
Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
Section 50569-3
Ask a doctor before use if you have
■ liver disease
■ a breathing problem such as emphysema or chronic bronchitis
■ difculty in urination due to enlargement of the prostate gland
■ glaucoma
Section 50570-1
Do not use
■ with any other product containing diphenhydramine, even one used on skin
■ in children under 12 years of age
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
■ if you have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6
croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide and triacetin
Section 51945-4
NDC 0904-6731-51
MAJOR
Extra Strength Acetaminophen PM Caplets
Acetaminophen and Diphenhydramine HCl
500mg/25mg
Pain Reliever/ Nighttime Sleep Aid
Compare to active ingredient oin Extra Strength TYLENOL PM*
50 Caplets
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Purpose
Pain reliever
Nighttime sleep-aid
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
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Other Information
store in a dry place at 15° – 30°C (59° – 86°F).
Questions Or Comments?
Call (800) 231-4670
Structured Label Content
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings and Precautions (34071-1)
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.
Section 34088-5 (34088-5)
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 42229-5 (42229-5)
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol®.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Questions or comments?
Call (800) 616-2471
www.majorpharmaceuticals.com
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 50566-9 (50566-9)
Stop use and ask a doctor if
■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. ■ new symptoms occur
■ redness or swelling is present
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Section 50567-7 (50567-7)
When using this product
■ avoid alcoholic beverages
■ do not drive a motor vehicle or operate machinery
■ drowsiness will occur
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
Section 50569-3 (50569-3)
Ask a doctor before use if you have
■ liver disease
■ a breathing problem such as emphysema or chronic bronchitis
■ difculty in urination due to enlargement of the prostate gland
■ glaucoma
Section 50570-1 (50570-1)
Do not use
■ with any other product containing diphenhydramine, even one used on skin
■ in children under 12 years of age
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
■ if you have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6 (51727-6)
croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide and triacetin
Section 51945-4 (51945-4)
NDC 0904-6731-51
MAJOR
Extra Strength Acetaminophen PM Caplets
Acetaminophen and Diphenhydramine HCl
500mg/25mg
Pain Reliever/ Nighttime Sleep Aid
Compare to active ingredient oin Extra Strength TYLENOL PM*
50 Caplets
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Purpose
Pain reliever
Nighttime sleep-aid
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
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Other Information (Other information)
store in a dry place at 15° – 30°C (59° – 86°F).
Questions Or Comments? (Questions or comments?)
Call (800) 231-4670
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:45.211671 · Updated: 2026-03-14T23:02:27.804765