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diphenhydramine hydrochloride by Lake Erie Medical DBA Quality Care Products LLC

Medically reviewed on January 13, 2017

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Lake Erie Medical DBA Quality Care Products LLC
NDC Code: 35356-865

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine Hydrochloride 25 mg

Diphenhydramine Hydrochloride 50 mg

Purpose

Antihistamine

Uses

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

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

Warnings

Ask a doctor before use if you have

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

Do not use with ny other product containing diphenhydramine, including products used topically.

Ask a doctor or pharmacist before use if you are

  • taking tranquilizers or sedatives
  • taking other products containing diphenhydramine

When using this product

  • Do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution when driving a motor vehicle or operating machinery

If pregnant or breastfeeding ask a health professional before use.

Keep out of the reach of children.

 In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • Adults and Children 12 years and over: 25 to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours.
  • Children 12 years and under: Consult a Doctor

Inactive ingredients

Colloidal Silicon Dioxide, Corn Starch, D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Anhydrous Lactose, Magnesium Stearate, Silicon Dioxide and Sodium Lauryl Sulfate.

Storage and Handling

Keep tightly closed. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

Manufactured for Sandoz Inc.

Princeton, NJ 08540

Manufactured by Epic Pharma, LLC

Laurelton, NY 11413

L1812

Rev. 11/08

Image of Label

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35356-865(NDC:0185-0648)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorPINK (pink top/clear body) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeE648
Contains    
Packaging
#Item CodePackage Description
1NDC:35356-865-1515 CAPSULE in 1 BOTTLE
2NDC:35356-865-2020 CAPSULE in 1 BOTTLE
3NDC:35356-865-2121 CAPSULE in 1 BOTTLE
4NDC:35356-865-3030 CAPSULE in 1 BOTTLE
5NDC:35356-865-6060 CAPSULE in 1 BOTTLE
6NDC:35356-865-9090 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2000
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIOperations
Lake Erie Medical DBA Quality Care Products LLC831276758repack(35356-865)

 
Lake Erie Medical DBA Quality Care Products LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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