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

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg


Medication Information

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.

Purpose

Nighttime sleep-aid

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 

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

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.

Packaging

Drug Facts

Questions Or Comments?

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

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg


Structured Label Content

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.

Purpose

Nighttime sleep-aid

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 

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

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.

Packaging

Drug Facts

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)