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.

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

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