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

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.

Uses

• for relief of occasional sleeplessness

• reduces time to fall asleep 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 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

Description

Diphenhydramine HCI 50 mg

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.

Packaging

Drug Facts

Questions Or Comments?

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

Active Ingredient (in Each Softgel)

Diphenhydramine HCI 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 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.

Uses

• for relief of occasional sleeplessness

• reduces time to fall asleep 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 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

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.

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 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