DIPHENHYDRAMINE HYDROCHLORIDE capsule

Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each banded capsule)

Diphenhydramine HCI 25 mg

PURPOSE

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• sneezing
• itchy, watery eyes n itching of the nose or throat

temporarily relieves these symptoms due to the common cold:

• runny nose
• sneezing

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

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 INGREDIENT

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?

1-800-231-4670

SPL UNCLASSIFIED SECTION

DO NOT USE IF PRODUCT APPEARS TO BE TAMPERED WITH OR IF BLISTER UNIT IS BROKEN OR TORN. DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING. KEEP THIS BOX FOR IMPORTANT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313

Product of China.

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

PRINCIPAL DISPLAY PANEL

Allergy Capsules

Diphenhydramine HCl, 25 mg | Antihistamine

For Allergy Relief:
Runny Nose
Itchy Throat
Sneezing
Itchy, Watery Eyes

COMPARE TO BENADRYL® ALLERGY active ingredient*

24 Capsules

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0598
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
GELATIN (UNII: 2G86QN327L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
D&C RED NO. 28 (UNII: 767IP0Y5NH)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0598-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2022
2	NDC: 70000-0598-1	2 in 1 CARTON	07/07/2022
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/07/2022

Labeler - LEADER/ Cardinal Health 110, Inc. (063997360)