0752-major

0752-major
SPL v5
SPL
SPL Set ID 786dbcd5-f5c2-4491-e053-2991aa0a3437
Route
ORAL
Published
Effective Date 2024-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg) Acetaminophen (500 mg)
Inactive Ingredients
D&c Yellow No. 10 Light Mineral Oil Povidone K30 Triacetin Hypromelloses Starch, Corn Croscarmellose Fd&c Blue No. 1 Magnesium Stearate Silicon Dioxide Stearic Acid Sodium Starch Glycolate Type A Potato Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: CPC752 Shape: oval Color: blue Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-26

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

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