Right Remedies

Right Remedies
SPL v1
SPL
SPL Set ID 8badbaad-eb35-4251-a779-00474819360d
Route
ORAL
Published
Effective Date 2023-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Croscarmellose Sodium Fd&c Blue No. 1 Aluminum Lake Fd&c Blue No. 2 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone K30 Water Silicon Dioxide Sodium Starch Glycolate Type A Starch, Corn Talc Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-13

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Purpose

Pain reliever Nighttime sleep aid


Medication Information

Purpose

Pain reliever Nighttime sleep aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Uses

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

Section 42229-5

compare to active ingredients of Extra Strength TYLENOL® PM*

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

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol® PM.

Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

Product of India

Packaged & Quality Assured in USA

CT7069214903

REV.00-082021

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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Purposes

Pain reliever

Nighttime sleep aid

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 a 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.

Packaging

Directions

do not take more than directed (see overdose warning)

• do not take more than 2 caplets in 24 hours

 adults & children

12 years of age and over

 • take 2 caplets at bedtime

 • do not take more than 2 caplets of this product in 24 hours

 children under 12 years of age  do not use

Drug Facts

Other Information

each caplet contains: sodium 3 mg (very low sodium)

• store at room temperature between 20-25ºC (68-77ºF).

• avoid excessive heat, cold and humidity.

Inactive Ingredients

croscarmellose sodium, FD&C blue#1 aluminium lake, FD&C blue#2 aluminium lake, hypromelloses, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone K30, purified water, silicon dioxide, sodium starch glycolate, starch, talc, titanium dioxide

Questions Or Comments?

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

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

compare to active ingredients of Extra Strength TYLENOL® PM*

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

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol® PM.

Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

Product of India

Packaged & Quality Assured in USA

CT7069214903

REV.00-082021

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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Purposes

Pain reliever

Nighttime sleep aid

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 a 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.

Packaging

Directions

do not take more than directed (see overdose warning)

• do not take more than 2 caplets in 24 hours

 adults & children

12 years of age and over

 • take 2 caplets at bedtime

 • do not take more than 2 caplets of this product in 24 hours

 children under 12 years of age  do not use

Drug Facts

Other Information (Other information)

each caplet contains: sodium 3 mg (very low sodium)

• store at room temperature between 20-25ºC (68-77ºF).

• avoid excessive heat, cold and humidity.

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, FD&C blue#1 aluminium lake, FD&C blue#2 aluminium lake, hypromelloses, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone K30, purified water, silicon dioxide, sodium starch glycolate, starch, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

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

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)