Drug Facts

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

Purpose
Nighttime sleep-aid

Use

for relief of occasional sleeplessness

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

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

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

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.

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

Directions

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

Other information

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

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.

Questions or comments?

1-800-231-4670

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.

Compare to the active ingredient in Unisom® SleepMinis®*

Nighttime
DIPHENHYDRAMINE HCl, 25 mg
Nighttime sleep-aid
Non-habit forming

120 MINI-CAPSULES

CVS Label

DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51316-347
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	5347
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51316-347-05	1 in 1 CARTON	02/02/2023
1		120 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:51316-347-06	365 in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M010	02/02/2023

Labeler - CVS Pharmacy, Inc (062312574)

5347K-CVS

Drug Facts

Use

Directions

Other information

Questions or comments?