5347k-cvs - DailyMed Details

5347k-cvs

SPL v2

SPL

SPL Set ID f5b609e1-e63b-2e3b-e053-2995a90a76b9

Route

ORAL

Published

Effective Date 2023-04-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Fd&c Blue No. 1 Lactose Monohydrate Gelatin Magnesium Stearate Titanium Dioxide Potassium Sorbate Starch, Corn Sodium Lauryl Sulfate Fd&c Red No. 3 Anhydrous Citric Acid Polysorbate 80

Identifiers & Packaging

Pill Appearance

Imprint: 5347 Shape: capsule Color: blue Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-02-02

Description

Active ingredient (in each mini-capsule) Diphenhydramine HCl 25 mg

Medication Information

Description

Active ingredient (in each mini-capsule) Diphenhydramine HCl 25 mg

Use

for relief of occasional sleeplessness

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 42229-5

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2023 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.

V-34571

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademarks Unisom® and SleepMinis®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF BLUE BAND AROUND CAPSULE IS BROKEN OR MISSING.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50567-7

When using this product avoid alcoholic beverages.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 50569-3

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Section 50570-1

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

Section 51727-6

anhydrous citric acid, corn starch, FD&C blue #1, FD&C red #3, gelatin, lactose monohydrate, magnesium stearate, polysorbate 80, potassium sorbate, sodium lauryl sulfate, titanium dioxide.

Section 51945-4

Compare to the active ingredient in Unisom® SleepMinis®*

Nighttime

DIPHENHYDRAMINE HCl, 25 mg

Nighttime sleep-aid

Non-habit forming

120 MINI-CAPSULES

Section 53414-9

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

Section 55105-1

Purpose

Nighttime sleep-aid

Directions

adults and children 12 years and over: take 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor

Drug Facts

Active ingredient (in each mini-capsule)

Diphenhydramine HCl 25 mg

Other Information

store in a dry place at 15° – 30°C (59° – 86°F)
use by expiration date on package
protect from moisture

Questions Or Comments?

1-800-231-4670

Structured Label Content

Use

for relief of occasional sleeplessness

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 42229-5 (42229-5)

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademarks Unisom® and SleepMinis®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF BLUE BAND AROUND CAPSULE IS BROKEN OR MISSING.

Section 50565-1 (50565-1)

Keep out of reach of children.

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 a serious underlying medical illness.

Section 50567-7 (50567-7)

When using this product avoid alcoholic beverages.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 50569-3 (50569-3)

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

anhydrous citric acid, corn starch, FD&C blue #1, FD&C red #3, gelatin, lactose monohydrate, magnesium stearate, polysorbate 80, potassium sorbate, sodium lauryl sulfate, titanium dioxide.

Section 51945-4 (51945-4)

Compare to the active ingredient in Unisom® SleepMinis®*

Nighttime

DIPHENHYDRAMINE HCl, 25 mg

Nighttime sleep-aid

Non-habit forming

120 MINI-CAPSULES

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Nighttime sleep-aid

Directions

adults and children 12 years and over: take 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor

Drug Facts

Active ingredient (in each mini-capsule)

Diphenhydramine HCl 25 mg

Other Information (Other information)

store in a dry place at 15° – 30°C (59° – 86°F)
use by expiration date on package
protect from moisture

Questions Or Comments? (Questions or comments?)

1-800-231-4670

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "for relief of occasional sleeplessness", "34088-5": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "42229-5": "Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2023 CVS/pharmacy CVS.com® 1-800-SHOP CVS Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients. V-34571 *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademarks Unisom® and SleepMinis®. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF BLUE BAND AROUND CAPSULE IS BROKEN OR MISSING.", "50565-1": "Keep out of reach of children.", "50566-9": "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.", "50567-7": "When using this product avoid alcoholic beverages.", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.", "50569-3": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland", "50570-1": "for children under 12 years of age with any other product containing diphenhydramine, even one used on skin", "51727-6": "anhydrous citric acid, corn starch, FD&C blue #1, FD&C red #3, gelatin, lactose monohydrate, magnesium stearate, polysorbate 80, potassium sorbate, sodium lauryl sulfate, titanium dioxide.", "51945-4": "Compare to the active ingredient in Unisom® SleepMinis®* Nighttime DIPHENHYDRAMINE HCl, 25 mg Nighttime sleep-aid Non-habit forming 120 MINI-CAPSULES", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "55105-1": "Purpose Nighttime sleep-aid", "Directions": "adults and children 12 years and over: take 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor", "Drug Facts": "Active ingredient (in each mini-capsule) Diphenhydramine HCl 25 mg", "Other information": "store in a dry place at 15° – 30°C (59° – 86°F) use by expiration date on package protect from moisture", "Questions or comments?": "1-800-231-4670"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:47.082740 · Updated: 2026-03-14T23:02:30.868416