ALLERGY MEDICINE- diphenhydramine hcl capsule 
L&R Distributors, Inc.

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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Select Brand 44-190-delisted

Active ingredient (in each banded capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

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

If pregnant of 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 (1-800-222-1222) right away.

Directions

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours

adults and children12 years and over

1 to 2 capsules
children 6 to under 12 years
1 capsule
children under 6

do not use

Other information

  • TAMPER EVIDENT: PRODUCT SEALED IN PLASTIC STRIPS, CAPSULE BANDED FOR YOUR PROTECTION. DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.
  •  store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number

Inactive ingredients

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

select brand®
the lower price name brand

NDC 15127-283-48

Allergy Medicine
Diphenhydramine HCl, 25 mg
Antihistamine

              Allergy Relief For:
Sneezing                        Runny Nose
Itchy, Watery Eyes          Itchy Throat

*Compare to the Active Ingredient of Benadryl®

48 CAPSULES

Actual Size
Each capsule individually
banded for your protection

TAMPER EVIDENT: PRODUCT SEALED IN PLASTIC STRIPS, CAPSULE BANDED FOR YOUR PROTECTION. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark
Benadryl®.                        
50844       REV1016C19022

Satisfaction Guaranteed
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Distributed by:
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Pine Bluff, AR 71603  USA
AC (870) 535-3635

Select Brand 44-190

Select Brand 44-190

ALLERGY MEDICINE 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-283
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorPINK, WHITEScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code 44;107
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-283-242 in 1 CARTON03/15/199009/10/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:15127-283-484 in 1 CARTON03/15/199009/10/2021
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:15127-283-12100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/199009/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/15/199009/10/2021
Labeler - L&R Distributors, Inc. (012578514)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(15127-283)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088MANUFACTURE(15127-283) , PACK(15127-283)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(15127-283)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(15127-283)

Revised: 10/2018
 
L&R Distributors, Inc.