DIPHENHYDRAMINE HCL capsule

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each mini-capsule)

Diphenhydramine HCl 25mg

PURPOSE

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness

WARNINGS

Do not use

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

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.

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 Poison Control Center (1-800-222-1222) right away.

Directions

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

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

INACTIVE INGREDIENT

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

Question or comments?

1-800-231-4670

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

CVSHealth

Compare to the active ingredient in Unisom® SleepMinis™*

Nighttime Sleep-Aid

Diphenhydramine HCl, 25mg

Nighttime sleep-aid

Non-habit forming

60 Mini-Capsules

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-537
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GELATIN (UNII: 2G86QN327L)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-537-11	1 in 1 CARTON	06/22/2018
1		60 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69842-537-51	365 in 1 BOTTLE; Type 0: Not a Combination Product	06/22/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	06/22/2018

Labeler - CVS Pharmacy, Inc. (062312574)