good remedies

good remedies
SPL v2
SPL
SPL Set ID 2d642d8e-c154-a970-e063-6294a90a03bf
Route
oral
Published
Effective Date 2025-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg) diphenhydramine (25 mg)
Inactive Ingredients
fd&c blue no. 1 fd&c blue no. 2 hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol 400 povidone, unspecified starch, corn stearic acid titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-17

Purpose

Pain reliever Nighttime sleep aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg


Medication Information

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

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.

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.

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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

Other Information

• store at room temperature between 20°-25°C(68°-77°F)

• protect from light, heat and moisture

Inactive Ingredients

FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinylpyrrolidone, pregelatinized starch, stearic acid powder, titanium dioxide

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Section 42229-5

Compare to the active ingredients of Extra Strength Tylenol® PM*

Distributed by:

Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

PRODUCT OF INDIA

*This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademark Tylenol®.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Section 50565-1

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

Packaging

Drug Facts

Active Ingredients 

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Questions Or Comments?

1-888-577-8033 Monday - Friday 8am - 4pm EST


Structured Label Content

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

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.

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.

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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

Other Information (Other information)

• store at room temperature between 20°-25°C(68°-77°F)

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinylpyrrolidone, pregelatinized starch, stearic acid powder, titanium dioxide

Section 42229-5 (42229-5)

Compare to the active ingredients of Extra Strength Tylenol® PM*

Distributed by:

Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

PRODUCT OF INDIA

*This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademark Tylenol®.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

Packaging

Drug Facts

Active Ingredients  (Active ingredients )

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday - Friday 8am - 4pm EST


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)