Right Remedies

Right Remedies
SPL v2
SPL
SPL Set ID 2d64f5c2-dfa9-e5f5-e063-6294a90a0711
Route
ORAL
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Fd&c Blue No. 1 Gelatin, Unspecified Glycerin Polyethylene Glycol 400 Propylene Glycol Sorbitol Sorbitan Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-19

Description

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

Uses
  • for relief of occasional sleeplessness
  • reduces time to fall alseep if you have difficulty falling asleep
Section 42229-5

Compare to the active ingredient of Unisom ® SleepGels®*

fall asleep fast safe, non-habit forming

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

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

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

PRODUCT OF INDIA

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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have

  • glaucoma
  • heart disease
  • a breathing problem such as emphysema, asthma, or chronic bronchitis
  • difficulty in urination due to an enlargement of prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers, or any other sleep aid

When using this product

  • avoid alcoholic beverages and other drugs that cause drowsiness.
  • be careful when driving a motor vehicle or operating machinery.

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.

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

Packaging

Directions

adults and children 12 years and over  take 1 softgel (50mg) at bedtime if needed, or as directed by a doctor
children under 12 years  do not use

Drug Facts

Other Information
  • store at room temperature between 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light, heat and moisture
Inactive Ingredients

edible ink, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide

Questions Or Comments?

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

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 50 mg


Structured Label Content

Uses
  • for relief of occasional sleeplessness
  • reduces time to fall alseep if you have difficulty falling asleep
Section 42229-5 (42229-5)

Compare to the active ingredient of Unisom ® SleepGels®*

fall asleep fast safe, non-habit forming

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

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

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

PRODUCT OF INDIA

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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have

  • glaucoma
  • heart disease
  • a breathing problem such as emphysema, asthma, or chronic bronchitis
  • difficulty in urination due to an enlargement of prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers, or any other sleep aid

When using this product

  • avoid alcoholic beverages and other drugs that cause drowsiness.
  • be careful when driving a motor vehicle or operating machinery.

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.

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

Packaging

Directions

adults and children 12 years and over  take 1 softgel (50mg) at bedtime if needed, or as directed by a doctor
children under 12 years  do not use

Drug Facts

Other Information (Other information)
  • store at room temperature between 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light, heat and moisture
Inactive Ingredients (Inactive ingredients)

edible ink, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide

Questions Or Comments? (Questions or comments?)

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

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Diphenhydramine HCl 50 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)