DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
Lake Erie Medical DBA Quality Care Products LLC

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Active Ingredient (in each banded capsule)

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Purpose

Antihistamine

Use

25 MG

50 MG

WARNINGS

Do not use

25 MG

50 MG

Ask a doctor before use if you have

25 MG

50 MG

Ask a doctor or pharmacist

before use if you are taking sedatives or tranquilizers

When using this product

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

25 MG

adults and children 12 years of age and over1 to 2 capsules
children 6 years to under 12 years of age1 capsule
children under 6 years of agedo not use this product in children under 6 years of age

50 MG

adults and children 12 years of age and over1 capsule
children 6 years to under 12 years of ageAsk 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

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

image description

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55700-580(NDC:0904-5306)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINK (half pink and half clear with white powder inside) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;835
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55700-580-2020 in 1 BOTTLE; Type 0: Not a Combination Product02/02/201810/11/2019
2NDC:55700-580-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/12/201804/30/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00901/12/201804/30/2025
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIBusiness Operations
Lake Erie Medical DBA Quality Care Products LLC831276758repack(55700-580)

Revised: 12/2023
Document Id: 176e30a2-660e-4874-8c08-649c356d6fa8
Set id: ec1dfb8a-e42d-4c1b-9d0a-20e6ef9468c6
Version: 6
Effective Time: 20231221
 
Lake Erie Medical DBA Quality Care Products LLC