DIPHENHYDRAMINE- diphenhydramine hydrochloride capsule 
PURINEPHARMA LLC

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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DIPHENHYDRAMINE HCl CAPSULES

Active Ingredient (each banded capsule contains)
Diphenhydramine HCL 50 mg

Purpose
Antihistaminne

Uses

Ask a doctor before use if you have

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

Do not use to make a child sleepy

Do not use with any other product containing diphenhydramine, even one used on skin

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:

Adults and Children 12 years of age and over1 to 2 capsules
Children 6 to under 12 years of age1 capsule
Children under 6 years of ageDo not use

Other information

D&C red 28, gelatin, lactose monohydrate, magnesium stearate, maize starch, polysorbate tween 80, silica gel.

Pack Size: 50 Capsules in a Bottle
Batch No.:
Mfg. Date:
Exp. Date:

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

NDC 58599-004-90
NDC 58599-004-25
NDC 58599-004-29
NDC 58599-004-35

Manufactured By: PURINEPHARMA LLC
5 County Route 42
Massena, NY – 13662
www.purinepharma.com

50000 Capsules
Carton for 50 Capsules in a Bottle
DIPHENHYDRAMINE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58599-004
Route of AdministrationORAL, Type 0: Not a Combination Product
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Product Characteristics
ColorPINK (PINK CAP and PINK BODY) Score2 pieces
ShapeCAPSULESize14mm
FlavorImprint Code DH;50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58599-004-9050000 in 1 BOX
2NDC:58599-004-251 in 1 CARTON
250 in 1 BOTTLE
3NDC:58599-004-291 in 1 CARTON
3100 in 1 BOTTLE
4NDC:58599-004-351 in 1 CARTON
41000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/2014
Labeler - PURINEPHARMA LLC (019950491)
Registrant - PURINEPHARMA LLC (019950491)
Establishment
NameAddressID/FEIBusiness Operations
PURINEPHARMA LLC019950491manufacture(58599-004)

Revised: 8/2014
Document Id: 4924194e-5c66-4af3-b83a-5367a10248a2
Set id: dac2e27b-126b-4773-9e8e-5186ca9965fa
Version: 6
Effective Time: 20140814
 
PURINEPHARMA LLC