MAXIMUM STRENGTH SLEEP AID- diphenhydramine hcl capsule, gelatin coated

MAXIMUM STRENGTH SLEEP AID by

Drug Labeling and Warnings

MAXIMUM STRENGTH SLEEP AID by is a Otc medication manufactured, distributed, or labeled by KROGER COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)                           

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

for the 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 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 drinks

Stop use and ask a doctor if

sleeplessness persist continuosly for more than 2 weeks. Insomnia may be a symptom of 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. 1-800-222-1222

Directions

• adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime, if needed, or as directed by a doctor

Inactive ingredients

FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water

Questions or comments?

1-800-632-6900

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

GLUTEN FREE

PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient of
UNISOM® SLEEPGELS®**

NDC: 30142-672-80

Kroger®

NIghttime Sleep-Aid

Sleep-Aid Softgels
MAXIMUM STRENGTH

Diphenhydramine HCI 50 mg

Helps to reduce difficulty falling asleep

Safe, Non-Habit Forming

2 Bottles (96ct each)

TWO BOTTLES INSIDE

LIQUID FILLED SOFTGELS one softgel per dose

actual size

**Unisom® SleepGels® is a registered trademark
of Chattem, Inc., Chattanooga, TN 37409.
Chattem, Inc., is not affiliated with The Kroger Co.
or this product.

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH SLEEP AID 
diphenhydramine hcl capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-672
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
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	206
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-672-80	2 in 1 CARTON	08/22/2019
1		96 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 30142-672-96	96 in 1 BOTTLE; Type 0: Not a Combination Product	08/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	08/22/2019

Labeler - KROGER COMPANY (006999528)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LIMITED		677385498	manufacture(30142-672)