DailyMed - DIPHENHYDRAMINE HCL capsule

NDC Code(s): 82568-0004-1, 82568-0004-2, 82568-0005-1, 82568-0005-2
Packager: AARNA USA INC.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated May 30, 2025

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Active ingredient (in each banded capsule)
Diphenhydramine Hydrochloride 25 mg and 50 mg

Diphenhydramine Hydrochloride 25 mg and 50 mg
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Purpose
Antihistamine

Antihistamine
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Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose - sneezing - itchy, watery eyes - itching of the nose or throat
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
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Warnings
Do not use - to make a child sleepy - with any other product containing diphenhydramine, even one used on skin - Ask a doctor before use if you have - glaucoma - difficulty in urination due to ...
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
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 (1-800-222-1222) right away.

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Directions

take every 4 to 6 hours - do not take more than 6 doses in 24 hours - 25 mg Dosage: AgeDose - adults and children 12 years and over1 to 2 capsules - children 6 to under 12 years of age1 ...

Other information
store at room temperature 20 º-25 ºC(68 º-77 ºF) do not use if either capsule band or imprinted safety seal under cap is broken or missing - protect from moisture
- store at room temperature 20 º-25 ºC(68 º-77 ºF)
- do not use if either capsule band or imprinted safety seal under cap is broken or missing
- protect from moisture
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Inactive ingredients
Colloidal silicon dioxide, Gelatin, Lactose Monohydrate, Magnesium Stearate, Microcrystalline cellulose

Colloidal silicon dioxide, Gelatin, Lactose Monohydrate, Magnesium Stearate, Microcrystalline cellulose
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Questions or comments?
Call toll-free 1-877-225-6999 - Manufactured for: AARNA USA INC - Leland, NC 28451

Call toll-free 1-877-225-6999

Manufactured for:

AARNA USA INC

Leland, NC 28451
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PRINCIPAL DISPLAY PANEL
...

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Age	Dose
adults and children 12 years and over	1 capsules
children under 12 years of age	ask a doctor, the proper dosage strength is not available in this package**

INGREDIENTS AND APPEARANCE

Product Information

DIPHENHYDRAMINE HCL diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82568-0004
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)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	pink (PINK WHITE)	Score	no score
Shape	CAPSULE (oblong)	Size	15mm
Flavor		Imprint Code	AD25
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82568-0004-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2025
2	NDC:82568-0004-2	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	12/06/2024

DIPHENHYDRAMINE HCL diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82568-0005
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	pink (PINK PINK)	Score	no score
Shape	CAPSULE (oblong)	Size	15mm
Flavor		Imprint Code	AD50
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82568-0005-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2025
2	NDC:82568-0005-2	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	05/30/2025

Labeler - AARNA USA INC. (118515992)

Name	Address	ID/FEI	Business Operations
Establishment
KJD PHARMA PRIVATE LIMITED		877256314	manufacture(82568-0004, 82568-0005)

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Label: DIPHENHYDRAMINE HCL capsule

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Drug Label Info

Safety

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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

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

Age	Dose
adults and children 12 years and over	1 to 2 capsules
children 6 to under 12 years of age	1 capsule
children under 6 years of age	do not use this product in children under 6 years of age

	NDC
1	82568-0004-1
2	82568-0004-2
3	82568-0005-1
4	82568-0005-2

Label: DIPHENHYDRAMINE HCL capsule

View Package Photos

VIEW MORE

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

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

DIPHENHYDRAMINE HCL capsule

Number of versions: 1

DIPHENHYDRAMINE HCL capsule

DIPHENHYDRAMINE HCL capsule

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DIPHENHYDRAMINE HCL capsule

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