Drug Facts

Active ingredient (in each capsule)
Diphenhydramine HCl 25 mg

Purpose
Antihistamine

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

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
 a breathing problem such as emphysema or chronic bronchitis

 glaucoma

 trouble urinating due to an enlarged prostate gland

This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

 marked drowsiness may occur

 avoid alcoholic drinks

 alcohol, sedatives and tranquilizers may increase drowsiness

 be careful when driving a motor vehicle or operating machinery

 excitability may occur, especially in children

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

 take every 4 to 6 hours, or as directed by a doctor

 do not take more than 6 doses in 24 hours

adults and children

12 years of age 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

Other information

 store in a dry place at 15° – 30°C (59° – 86°F)

Inactive Ingredients: corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Questions or comments?

1-800-616-2471

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.

KEEP OUT OF REACH OF CHILDREN.

DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING.

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Distributed by:

Cardinal Health

Dublin, OH 43017

Product of China.

Manufactured and packaged in the USA using domestic and imported ingredients.

L58294370124

Principal Display Panel

Diphenhydramine HCL Capsules

25 mg

10 Capsules

DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55154-2344(NDC:0904-7237)
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
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	pink (Half pink and half clear with white powder inside and sealed with red band)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	CPC;835
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55154-2344-0	10 in 1 BAG	04/14/2022
1		1 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	M012	04/14/2022

Labeler - Cardinal Health 107, LLC (118546603)