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.
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
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
Other Information
store in a dry place at 15° – 30°C (59° – 86°F).
Description
Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg
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
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Questions Or Comments?
Call (800) 231-4670
Structured Label Content
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.
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
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
Other Information (Other information)
store in a dry place at 15° – 30°C (59° – 86°F).
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
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
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