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Diphenhydramine by Rebel Distributors Corp

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Rebel Distributors Corp
NDC Code: 21695-304

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.

Diphenhydramine Drug Facts

Active ingredient

Diphenhydramine HCl 25mg

Diphenhydramine HCl 50mg

Purpose

Antihistamine

Keep Out of Reach of Children

Uses

Temporarily relieves: ° hay fever or other upper respiratory allergies like: ° runny nose

° sneezing ° watery eyes ° itchy nose or throat

Warnings

Do not use with any other product containing Diphenhydramine HCl, including one applied topically.

Ask a doctor or pharmacist before use if you have ° trouble urinating due to enlarged prostate gland ° a breathing problem such as emphysema or chronic bronchitis ° glaucoma ° if you are taking sedatives or tranquilizers

When using this product ° avoid alcoholic drinks ° marked drowsiness may occur ° excitability may occur, especially in children ° alcohol, sedatives & tranquilizers may increase drowsiness ° be careful when driving a motor vehicle or operating machinery.

If pregnant or breast-feeding, ask a health professional before use.

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.

Adults & children 12 years & over: 1-2 capsules

Children 6 to under 12 years: 1 capsule

Children under 6: ask a doctor

Other Information

Store at room temperature 15°-30°C (59°-86°F)

Protect from excessive moisture

Inactive ingredients

Lactose Monohydrate, Silicon Dioxide, Magnesium Steareate, Black Iron Oxide, Gelatin, Sodium Lauyl Sulfate, D&C Red No. 28, FD&C Red No. 40, FD&C Blue No. 1.

Distributed by:

SDA Laboratories, Inc.

Greenwich, CT 06830

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Package/Label Principal Display Panel

Package/Label Principal Display Panel

DIPHENHYDRAMINE 
diphenhydramine capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-304(NDC:66424-020)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
SILICON DIOXIDE 
MAGNESIUM STEARATE 
FERROSOFERRIC OXIDE 
GELATIN 
SODIUM LAURYL SULFATE 
D&C RED NO. 28 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
Product Characteristics
ColorPINK (Pink/White) Scoreno score
ShapeCAPSULESize15mm
FlavorImprint CodePH;014
Contains    
Packaging
#Item CodePackage Description
1NDC:21695-304-1515 CAPSULE (CAPSULE) in 1 BOTTLE
2NDC:21695-304-2020 CAPSULE (CAPSULE) in 1 BOTTLE
3NDC:21695-304-2424 CAPSULE (CAPSULE) in 1 BOTTLE
4NDC:21695-304-3030 CAPSULE (CAPSULE) in 1 BOTTLE
5NDC:21695-304-9090 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2007
DIPHENHYDRAMINE 
diphenhydramine capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-500(NDC:66424-021)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
SILICON DIOXIDE 
MAGNESIUM STEARATE 
FERROSOFERRIC OXIDE 
GELATIN 
SODIUM LAURYL SULFATE 
D&C RED NO. 28 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize15mm
FlavorImprint CodePH;013
Contains    
Packaging
#Item CodePackage Description
1NDC:21695-500-1515 CAPSULE (CAPSULE) in 1 BOTTLE
2NDC:21695-500-2020 CAPSULE (CAPSULE) in 1 BOTTLE
3NDC:21695-500-3030 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2007
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 02/2011
 
Rebel Distributors Corp

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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