Nighttime Sleep-aid

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Fd&c Blue No. 1 Gelatin, Unspecified Glycerin Isopropyl Alcohol Medium-chain Triglycerides Polyethylene Glycol, Unspecified Povidone, Unspecified Water Sorbitol Sorbitan

Identifiers & Packaging

Pill Appearance

Imprint: 785 Shape: oval Color: blue Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-08-20

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCI 50 mg

Uses

• for relief of occasional sleeplessness

• reduces time to fall asleep if you have difficulty falling asleep

Section 42229-5

Compare to the active ingredient of Unisom^® SleepGels^®*

Maximum Strength

fall asleep fast safe, non-habit forming

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

This product i 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 UAE

Packaged and Quality Assured in the USA

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 enlargement of the 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 20-25°C (68-77°F)

• avoid excessive heat above 40°C (104°F)

• protect from light

Inactive Ingredients

edible ink, FD&C blue #1, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments?

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

Active Ingredient (in Each Softgel)

Diphenhydramine HCI 50 mg

Structured Label Content

Uses

• for relief of occasional sleeplessness

• reduces time to fall asleep if you have difficulty falling asleep

Section 42229-5 (42229-5)

Compare to the active ingredient of Unisom^® SleepGels^®*

Maximum Strength

fall asleep fast safe, non-habit forming

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

This product i 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 UAE

Packaged and Quality Assured in the USA

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 enlargement of the 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 20-25°C (68-77°F)

• avoid excessive heat above 40°C (104°F)

• protect from light

Inactive Ingredients (Inactive ingredients)

edible ink, FD&C blue #1, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

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 HCI 50 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "• for relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep", "42229-5": "Compare to the active ingredient of Unisom ® SleepGels ® * Maximum Strength fall asleep fast safe, non-habit forming TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE This product i 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 UAE Packaged and Quality Assured in the USA", "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 enlargement of the 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 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F) • protect from light", "Inactive ingredients": "edible ink, FD&C blue #1, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution", "Questions or comments?": "1-888-577-8033 Monday-Friday 8am-4pm EST", "Active ingredient (in each softgel)": "Diphenhydramine HCI 50 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information