DailyMed - SLEEP AID- diphenhydramine hcl tablet, film coated

NDC Code(s): 70000-0244-1
Packager: Cardinal Health 110, LLC. DBA Leader

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated March 8, 2025

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Active ingredient (in each caplet)
Diphenhydramine HCl 25 mg

Diphenhydramine HCl 25 mg

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Purpose
Nighttime sleep-aid

Nighttime sleep-aid
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Uses
for relief of occasional sleeplessness - reduces time to fall asleep if you have difficulty falling asleep
- for relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
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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 ...
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
- difficulty in urination due to enlargement of the prostate gland
- glaucoma
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 right away.

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Directions
do not take more than directed - adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor - children under 12 years: do not use
- do not take more than directed
- adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
- children under 12 years: do not use
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Other information
each caplet contains: calcium 30 mg - TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN - protect from moisture - store at 25°C (77°F); excursions permitted ...
- each caplet contains: calcium 30 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- protect from moisture
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
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Inactive ingredients
corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid ...

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide
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Questions or comments?
1-800-426-9391

1-800-426-9391
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Principal Display Panel
NDC 70000-0244-1 - LEADER™ Sleep-Aid - Diphenhydramine HCl, 25 mg - Nighttime Sleep-Aid - Non-Habit Forming - Not for Treating Pain, Cold or Flu - 24 CAPLETS - Actual Size - COMPARE TO - SIMPLY ...

NDC 70000-0244-1

LEADER™

Sleep-Aid
Diphenhydramine HCl, 25 mg
Nighttime Sleep-Aid

Non-Habit Forming
Not for Treating Pain,
Cold or Flu

24 CAPLETS

Actual Size

COMPARE TO
SIMPLY SLEEP®
NIGHTTIME SLEEP AID
active ingredient*

100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

✓All LEADER™ Brand Products Have A
100% Money Back Guarantee
Return to place of purchase if not satisfied.

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313
Essential to Care™ since 1979

© 2021 Cardinal Health. All Rights Reserved.
CARDINAL HEALTH, the Cardinal Health LOGO,
ESSENTIAL TO CARE, LEADER, and the Leader LOGO
are trademarks or registered trademarks of
Cardinal Health. All other marks are the property
of their respective owners.

*This product is not manufactured or distributed by Johnson &
Johnson Corporation, owner of the registered trademark Simply
Sleep® Nighttime Sleep Aid. 50844 REV1019A36708

Leader 44-367

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INGREDIENTS AND APPEARANCE

Product Information

SLEEP AID diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0244
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
STARCH, CORN (UNII: O8232NY3SJ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	44;367
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0244-1	2 in 1 CARTON	06/10/2000
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M010	06/10/2000

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(70000-0244)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(70000-0244) , pack(70000-0244)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(70000-0244)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	manufacture(70000-0244)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(70000-0244)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(70000-0244)

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Published Date (What is this?)	Version	Files
Mar 17, 2025	12 (current)	download
Mar 11, 2024	11	download
Oct 9, 2023	10	download
Mar 27, 2023	9	download
Mar 7, 2022	8	download
Jun 29, 2021	7	download
Mar 11, 2021	5	download
Aug 20, 2019	4	download
Feb 27, 2019	3	download
Feb 12, 2018	2	download
Feb 22, 2017	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN
2	1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD

Label: SLEEP AID- diphenhydramine hcl tablet, film coated

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

Label: SLEEP AID- diphenhydramine hcl tablet, film coated

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

SLEEP AID- diphenhydramine hcl tablet, film coated

Number of versions: 11

SLEEP AID- diphenhydramine hcl tablet, film coated

SLEEP AID- diphenhydramine hcl tablet, film coated

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SLEEP AID- diphenhydramine hcl tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.