5347-cvs

5347-cvs
SPL v4
SPL
SPL Set ID 6dd802ec-fc26-3913-e053-2a91aa0ad05d
Route
ORAL
Published
Effective Date 2019-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Anhydrous Lactose Fd&c Red No. 40 Potassium Sorbate Tetraiodofluorescein Polysorbate 80 Gelatin Starch, Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 5347 Shape: capsule Color: blue Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-22
Description

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

Medication Information

Description

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

Uses

for relief of occasional sleeplessness

Section 34088-5

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

Section 42229-5

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

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

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Section 51727-6

citric acid, edible ink, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, lactose, polysorbate 80, potassium sorbate, starch, titanium dioxide

Section 51945-4

CVSHealth

Compare to the active ingredient in Unisom® SleepMinis™*

Nighttime Sleep-Aid

Diphenhydramine HCl, 25mg

Nighttime sleep-aid

Non-habit forming

60 Mini-Capsules

Section 55105-1

Purpose

Nighttime sleep-aid

Directions
  • Adults and children 12 years and over: take 2 mini-capsules (50mg) at bedtime if nedded, or as directed by a doctor
Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Drug Facts

Active Ingredient (in each mini-capsule)

Diphenhydramine HCl 25mg

Other Information
  • Store at 25ºC(77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
  • protect from moisture
Question Or Comments?

1-800-231-4670

When Using This Product

avoid alcoholic beverages

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.

Keep Out of Reach of Children.

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic brochitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Uses

for relief of occasional sleeplessness

Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

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

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Section 51727-6 (51727-6)

citric acid, edible ink, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, lactose, polysorbate 80, potassium sorbate, starch, titanium dioxide

Section 51945-4 (51945-4)

CVSHealth

Compare to the active ingredient in Unisom® SleepMinis™*

Nighttime Sleep-Aid

Diphenhydramine HCl, 25mg

Nighttime sleep-aid

Non-habit forming

60 Mini-Capsules

Section 55105-1 (55105-1)

Purpose

Nighttime sleep-aid

Directions
  • Adults and children 12 years and over: take 2 mini-capsules (50mg) at bedtime if nedded, or as directed by a doctor
Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Drug Facts

Active Ingredient (in each mini-capsule)

Diphenhydramine HCl 25mg

Other Information
  • Store at 25ºC(77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
  • protect from moisture
Question Or Comments? (Question or comments?)

1-800-231-4670

When Using This Product (When using this product)

avoid alcoholic beverages

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic brochitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:38.505645 · Updated: 2026-03-14T23:05:32.543899