DALAY MAXIMUM STRENGTH- diphenhydramine hcl 25 mg tablet
Genomma Labs USA, Inc

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 tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Uses

for relief of occasional sleeplessness

Warnings

Do not use

with any other products containing diphenhydramine, including one used on skin
in children under 12 years of age

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

marked drowsiness may occur
avoid alcoholic beverages
do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

sleeplessness persists continuously 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately

Directions

Adults and children 12 years of age and older: take 2 tablets at bedtime if needed or as directed by a doctor

Children under 12 years of age: Do not use

Other information

store at room temperature
do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

croscarmellose sodium, dicalcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments

Call toll free 1-877-99 GENOM (43666)

Package/Label Principal Display Panel

Dalay Sleep-Aid

DALAY MAXIMUM STRENGTH
diphenhydramine hcl 25 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50066-247
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	BLUE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	AZ247
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50066-247-24	1 in 1 CARTON	04/21/2015	12/15/2021
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part338	04/21/2015	12/15/2021

Labeler - Genomma Labs USA, Inc (832323534)

Registrant - Allegiant Health (079501930)

Revised: 12/2021

Document Id: c8de3069-3f15-4214-8c04-cc6707fe89b0

Set id: 4792ae82-fa15-45ff-834f-f9231d272176

Version: 5

Effective Time: 20211209

Genomma Labs USA, Inc