Family Wellness 44-190

Drug Labeling and Warnings

Drug Details [pdf]

ALLERGY RELIEF- diphenhydramine hcl capsule 
Family Dollar Services 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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Family Wellness 44-190

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
  • 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 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 right away.

Directions

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
 adults and children 12
 years of age and over		 1 to 2 capsules
 children 6 to under 12
 years of age		 1 capsule
 children under 6
 years of age		 do not use this
 product in children
 under 6 years of age

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • 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, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silica gel

Questions or comments?

1-800-426-9391

Principal Display Panel

FAMILY
wellness™

COMPARE TO THE ACTIVE
INGREDIENT OFBENADRYL®*

100% SATISFACTION
GUARANTEED
OR YOUR MONEY BACK 

Allergy Relief
Diphenhydramine HCl 25 mg
Antihistamine

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

100 CAPSULES

ACTUAL SIZE

*This product is not manufactured or distributed by McNeil
Consumer Healthcare, owner of the registered trademark
Benadryl®.         50844        REV0512A19012

DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.,
10401 MONROE RD, MATTHEWS, NC 28105 USA

Not 100% satisfied?
Return package and unused product within 30 days
to any Family Dollar store for a refund (with receipt)
or exchange.

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

Family Wellness 44-190

Family Wellness 44-190

ALLERGY RELIEF 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55319-190
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)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorPINK, WHITEScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code 44;107
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55319-190-121 in 1 CARTON03/15/199010/25/2019
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/15/199010/25/2019
Labeler - Family Dollar Services Inc (024472631)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(55319-190)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(55319-190)

Revised: 1/2017
Document Id: 7599cd7c-d94c-4f1f-952f-31941d8cf819
Set id: bea35727-85c1-4f1f-bab2-71c3f8cf11b5
Version: 6
Effective Time: 20170103