Meijer Nighttime Sleep Aid

SPL v8

SPL

SPL Set ID 89e6daa7-79c0-408e-8b21-f3a03e6e7fbc

Route

ORAL

Published

Effective Date 2020-02-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol 400 Propylene Glycol Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 602 Shape: capsule Color: purple Size: 15 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-02-10

Description

Drug Facts

Purpose

nighttime sleep-aid

Medication Information

Warnings and Precautions

Warnings

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 50568-5

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

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
children under 12 years	Do not use

Do Not Use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin.

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#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol sorbitan, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

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

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

Active Ingredients (in Each Softgel)

Diphenhydramine HCl 25 mg

Structured Label Content

Uses

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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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 50568-5 (50568-5)

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

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
children under 12 years	Do not use

Do Not Use (Do not use)

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin.

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#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol sorbitan, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (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

Ask A Doctor Before Use If You Have (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

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

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

[{"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "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": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "34071-1": "Warnings", "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.", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers or any other sleep aid", "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 children under 12 years Do not use", "Do not use": "for children under 12 years of age with any other product containing diphenhydramine, even one used on skin.", "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#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol sorbitan, titanium dioxide", "Questions or comments?": "1-888-333-9792", "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", "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", "Active ingredients (in each softgel)": "Diphenhydramine HCl 25 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:58.557506 · Updated: 2026-03-14T23:06:11.878508