DIPHENHYDRAMINE HCL - diphenhydramine hcl capsule 
A-S Medication Solutions

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.

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Drug Facts

Active ingredient(in each capsule)

Diphenhydramine HCL 50 mg

Purpose

Antihistamine

Uses:

Warnings:


Do not use

Ask a doctor or pharmacist before use

If you haveTrouble urinating due to enlarged prostate glandA breathing problem such as emphysema or chronic bronchitisGlaucomaIf 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:

Take every 4-6 hoursDo not take more than 6 doses in 24 hours.Adults and children 12 years or over1 capsule                                      Children under 12 years ask a doctor**25 mg strength is not available in this package. Do not attempt to break capsules.

Other information:

Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate


Questions? Adverse drug event call:

1-800-687-0176

HOW SUPPLIED

Product: 50090-4539

NDC: 50090-4539-0 30 CAPSULE in a BOTTLE

NDC: 50090-4539-2 15 CAPSULE in a BOTTLE

NDC: 50090-4539-3 20 CAPSULE in a BOTTLE

NDC: 50090-4539-5 10 CAPSULE in a BOTTLE

NDC: 50090-4539-1 100 CAPSULE in a BOTTLE

Diphenhydramine HCL

Label Image
DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4539(NDC:66424-021)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code PH013
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-4539-030 in 1 BOTTLE; Type 0: Not a Combination Product09/20/2019
2NDC:50090-4539-215 in 1 BOTTLE; Type 0: Not a Combination Product09/20/2019
3NDC:50090-4539-320 in 1 BOTTLE; Type 0: Not a Combination Product09/20/2019
4NDC:50090-4539-510 in 1 BOTTLE; Type 0: Not a Combination Product09/20/2019
5NDC:50090-4539-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/27/2010
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-4539) , REPACK(50090-4539)

Revised: 5/2020
Document Id: a0539ad4-0f38-4164-b1dc-42083953f93a
Set id: 2ea8de9d-069e-4ec6-b536-7f8d9827f338
Version: 3
Effective Time: 20200529
 
A-S Medication Solutions