DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

NIGHTTIME SLEEP AID- diphenhydramine hcl capsule 
EQUALINE (SuperValu)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep- aid

Use

• helps to reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age.

Do not use this product

• With other products containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have

• emphysema
• chronic bronchitis
• glaucoma
• difficulty in urination due to an enlargement of the prostate gland

Ask doctor or pharmacist before use if you are now taking

sedatives or tranquilizers

When using this product

Avoid alcoholic beverages

Stop use and ask a doctor if

•  sleeplessness persists 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 right away.

Directions

• adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by a doctor

Other information

• Store at controlled room temperature 15°-30°C (59°-86°F)

Inactive ingredients

edible white ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special.

Questions or comments ?

call toll free 1-877-932-7948

Principal Display Panel

Compare to the Active Ingredient in Maximum Strength Unisom SleepGels® *

Maximum strength

Sleep aid

Diphenhydramine hydrochloride, 50 mg

helps to reduce difficulty in falling asleep

* This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom® SlepGels®

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Diphenhydramine HCl 50 mg

NIGHTTIME SLEEP AID 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-230
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	P50;A99
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-230-32	32 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2012	06/01/2019
2	NDC: 41163-230-96	96 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2012	06/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/03/2012	06/01/2019

Labeler - EQUALINE (SuperValu) (006961411)

Revised: 12/2018

Document Id: 566fcf30-463d-4f6d-83c1-9667f91646e8

34390-5

Set id: 0cf43545-f741-44e6-9a81-91d20a3c2f87

Version: 3

Effective Time: 20181205

 

EQUALINE (SuperValu)