Pure-aid

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol 400 Water Fd&c Red No. 40 Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: SLAD Shape: capsule Color: purple Size: 15 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2014-10-22

Medication Information

Purpose

nighttime sleep-aid

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222)

Section 50566-9

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.

Section 50567-7

When using this product

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

Section 50568-5

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

Section 50569-3

Ask a doctor before use if you have

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

Section 50570-1

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

Section 53414-9

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

Directions

take only one dose per day (24 hours) - see Overdose warning

adults & children

12 yrs & over

One dose = TWO 25 mg Softgels (50 mg)

at bed time if needed or as directed by a doctor

Other Information

store at 20-25° C (68-77° F)
avoid excessive heat above 40° C (104° F) and high humidity
Protect from light

Inactive Ingredients

FD&C blue No.1, FD&C Rd No. 40, gelatin, glycerin, polyethylene glycol 400, partially hydrated sorbitol liquid, purified water

Active Ingredients (in Each Softgel)

Diphenhydramine HCl 25 mg

Principal Display Panel 12 Capsule Carton

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222)

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product

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

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

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

Section 50570-1 (50570-1)

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

Section 53414-9 (53414-9)

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

Purpose

nighttime sleep-aid

Directions

take only one dose per day (24 hours) - see Overdose warning

adults & children

12 yrs & over

One dose = TWO 25 mg Softgels (50 mg)

at bed time if needed or as directed by a doctor

Other Information (Other information)

store at 20-25° C (68-77° F)
avoid excessive heat above 40° C (104° F) and high humidity
Protect from light

Inactive Ingredients (Inactive ingredients)

FD&C blue No.1, FD&C Rd No. 40, gelatin, glycerin, polyethylene glycol 400, partially hydrated sorbitol liquid, purified water

Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Diphenhydramine HCl 25 mg

Principal Display Panel 12 Capsule Carton (PRINCIPAL DISPLAY PANEL - 12 Capsule Carton)

Advanced Ingredient Data

[{"name": "Diphenhydramine", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "2", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C Blue No. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "gelatin", "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": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C Red No. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sorbitol", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222)", "50566-9": "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.", "50567-7": "When using this product avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep-aid", "50569-3": "Ask a doctor before use if you have a breathing problem such as asthma, emphysema, or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland heart disease", "50570-1": "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", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "Purpose": "nighttime sleep-aid", "Directions": "take only one dose per day (24 hours) - see Overdose warning adults & children 12 yrs & over One dose = TWO 25 mg Softgels (50 mg) at bed time if needed or as directed by a doctor", "Other information": "store at 20-25° C (68-77° F) avoid excessive heat above 40° C (104° F) and high humidity Protect from light", "Inactive ingredients": "FD&C blue No.1, FD&C Rd No. 40, gelatin, glycerin, polyethylene glycol 400, partially hydrated sorbitol liquid, purified water", "Active ingredients (in each softgel)": "Diphenhydramine HCl 25 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information