ALLERGY RELIEF- diphenhydramine hcl capsule 
Freds 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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Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

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

  • trouble urinating due to an enlarged prostate gland

  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

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 24 hours
  • swallow whole, do not crush, chew, or dissolve
 adults and children 12 years of age and over take 1 to 2 capsules 
 children 6 to under 12 years of age take 1 capsule
children under 6 years of age do not use

Other information

  • store between 15-30ºC (59-86ºF)
  • protect from light, heat and humidity

Inactive ingredients

edible dye free ink, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution.

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Benadryl® Liqui-Gels®*

Antihistamine

Allergy Relief

Diphenhydramine HCl 25 mg

Allergy Relief

Sneezing, itchy, watery eyes, runny nose, itchy thorat

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl®

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Product Label

Freds

Diphenhydramine HCl 25 mg

ALLERGY RELIEF 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-483
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
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorYELLOW (clear) Scoreno score
ShapeCAPSULESize15mm
FlavorImprint Code A33;SCU
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-483-242 in 1 BOX12/18/201512/30/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33612/18/201512/30/2021
Labeler - Freds Inc (005866116)
Registrant - P & L Development, LLC (079765031)

Revised: 12/2019
Document Id: ee2b3573-0b42-467d-9757-10d000c606ef
Set id: ac30f1df-aded-44da-8b0b-a94bce5f2dcf
Version: 3
Effective Time: 20191216
 
Freds Inc