DIPHENHYDRAMINE HYDROCHLORIDE capsule

Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Lake Erie Medical DBA Quality Care Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each banded capsule)

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Purpose

Antihistamine

Use

25 MG

• Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy throat and nose
• Temporarily relieves these symptoms due to the common cold:
  • runny nose
  • sneezing

50 MG

• Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy throat and nose

WARNINGS

Do not use

25 MG

• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin

50 MG

• to make a child sleepy
• with any other product containing diphenhydramine, including one applied topically

Ask a doctor before use if you have

25 MG

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland

50 MG

• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the 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.

Directions

• Take every 4-6 hours
• Do not take more than 6 doses in 24 hours

25 MG

• adults and children 12 years of age and over: 1 to 2 capsules
• children 6 years 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

50 MG

• adults and children 12 years of age and over: 1 capsule
• children 6 years to under 12 years of age: Ask a doctor, the proper dosage strength is not available in this package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information

• Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
• Protect from moisture
• Contains lactose

Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?

Questions or comments? (800) 616-2471

Distributed by

MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233,
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55700-580(NDC:0904-5306)
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
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
LACTOSE (UNII: J2B2A4N98G)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK (half pink and half clear with white powder inside)	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: 55700-580-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	02/02/2018	10/11/2019
2	NDC: 55700-580-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	01/12/2018

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)

Establishment
Name	Address	ID/FEI	Business Operations
Lake Erie Medical DBA Quality Care Products LLC		831276758	repack(55700-580)