Right Remedies 

Right Remedies 
SPL v2
SPL
SPL Set ID f99cc210-b946-42a2-9164-8aa5308c5418
Route
ORAL
Published
Effective Date 2023-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Fd&c Blue No. 1 Fd&c Blue No. 2 Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Talc Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-06

Description

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Use

• for relief of occasional sleeplessness

Section 42229-5

RIGHT REMEDIES

Compare to the active ingredient of TYLENOL®  Simply Sleep®*

helps you fall asleep 

safe, non-habit forming

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

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

Product of India

Packaged and Quality Assured in the USA

READ AND KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

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

REV.00-032022

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.

Warnings

Do not use

• for children under 12 years of age

• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma

• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

• avoid alcoholic drinks

• drowsiness will occur

• 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.

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions
 adults and children 12

 years of age and over
take 2 caplets at bedtime if

needed, or as directed by a doctor 
 children under 12 years

 of age
do not use 

Drug Facts

Other Information

each caplet contains: calcium 19 mg

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

• avoid excessive heat, light and moisture.

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1, FD&C blue #2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions Or Comments?

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

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg


Structured Label Content

Use

• for relief of occasional sleeplessness

Section 42229-5 (42229-5)

RIGHT REMEDIES

Compare to the active ingredient of TYLENOL®  Simply Sleep®*

helps you fall asleep 

safe, non-habit forming

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

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

Product of India

Packaged and Quality Assured in the USA

READ AND KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

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

REV.00-032022

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.

Purpose

Nighttime sleep-aid

Warnings

Do not use

• for children under 12 years of age

• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma

• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

• avoid alcoholic drinks

• drowsiness will occur

• 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.

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions
 adults and children 12

 years of age and over
take 2 caplets at bedtime if

needed, or as directed by a doctor 
 children under 12 years

 of age
do not use 

Drug Facts

Other Information (Other information)

each caplet contains: calcium 19 mg

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

• avoid excessive heat, light and moisture.

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dicalcium phosphate, FD&C blue #1, FD&C blue #2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

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

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)