right remedies

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

Medication Information

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.

Uses

for relief of occasional sleeplessness
reduces time to fall alseep if you have difficulty falling asleep

Purpose

Nighttime sleep-aid

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

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

Description

Diphenhydramine HCl 50 mg

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.

Packaging

Drug Facts

Questions Or Comments?

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

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 50 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
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.

Uses

for relief of occasional sleeplessness
reduces time to fall alseep if you have difficulty falling asleep

Purpose

Nighttime sleep-aid

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

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

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.

Packaging

Drug Facts

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

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occasional sleeplessness reduces time to fall alseep if you have difficulty falling asleep", "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", "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.", "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", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information