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DIPHENHYDRAMINE by PURINEPHARMA LLC

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: PURINEPHARMA LLC
NDC Code: 58599-004

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 HCl CAPSULES

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

Purpose
Antihistaminne

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, Watery eyes
    • itching of the nose or throat

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

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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 to 6 hours.
  • Do not take more than 6 doses in any 24-hour period.
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

  • Store between 15-30 degree Celsius (59-86 degree Fahrenheit)
  • Protect from moisture

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

DIPHENHYDRAMINE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58599-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 
GELATIN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
STARCH, CORN 
POLYSORBATE 80 
Product Characteristics
ColorPINK (PINK CAP and PINK BODY) Score2 pieces
ShapeCAPSULESize14mm
FlavorImprint CodeDH;50
Contains    
Packaging
#Item CodePackage Description
1NDC:58599-004-9050000 CAPSULE (CAPSULE) in 1 BOX
2NDC:58599-004-251 BOTTLE (1 BOTTLE) in 1 CARTON
250 CAPSULE (CAPSULE) in 1 BOTTLE
3NDC:58599-004-291 BOTTLE (1 BOTTLE) in 1 CARTON
3100 CAPSULE (CAPSULE) in 1 BOTTLE
4NDC:58599-004-351 BOTTLE (1 BOTTLE) in 1 CARTON
41000 CAPSULE (CAPSULE) 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/FEIOperations
PURINEPHARMA LLC019950491manufacture(58599-004)

 
PURINEPHARMA LLC

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Medically reviewed on Aug 14, 2018

Further information

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

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