ALLERGY RELIEF- diphenhydramine hydrochloride capsule, liquid filled 
FOODHOLD U.S.A., 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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Allergy Relief

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged 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 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 (1-800-222-1222).

Directions

adults and children 12 years and over

     1 to 2 softgels

children 6 to under 12 years

     1 softgel

children under 6 years

     do not use this product in children under 6 years of age

Other information

Inactive ingredients

gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Questions or comments?

Call: 1-855-215-8180

PRINCIPAL DISPLAY PANEL - Carton Label

CAREONE Allergy Relief

Diphenhydramine HCl 25 mg 24 softgels

NDC 41520-996-04

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

Carton Label

ALLERGY RELIEF 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-996
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)  
Product Characteristics
Coloryellow (clear) Scoreno score
Shapecapsule (oblong) Size15mm
FlavorImprint Code PC4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-996-042 in 1 CARTON10/03/2016
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 finalpart34110/03/2016
Labeler - FOODHOLD U.S.A., LLC (809183973)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(41520-996) , analysis(41520-996)

Revised: 11/2019
Document Id: 9c3b81eb-78de-4a39-a127-7875ee49d6e4
Set id: 508a65ee-42fa-4c0b-b24d-9faac6b0eba7
Version: 2
Effective Time: 20191120
 
FOODHOLD U.S.A., LLC