ALLERGY- diphenhydramine hydrochloride tablet 
FRED'S, 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.

----------

Freds 44-329

Active ingredient

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

  • 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 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

adults and children 12 years of age and over

1 to 2 tablets 
 children 6 to under 12 years of age 1 tablet   
 children under 6 years of age do not use this product in children under 6 years of age

Other information

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Principal Display Panel

FRED'S®

Allergy
Tablets
Antihistamine

Diphenhydramine HCl, 25 mg

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

24 Tablets

Tested Against The Active Ingredient in: BENADRYL® ALLERGY ULTRATAB®*

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark BENADRYL® ALLERGY ULTRATAB®.
50844      REV0410E32908

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

Fred's 44-329

Fred's 44-329

ALLERGY 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55315-329
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
D&C RED NO. 27 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code 44;329
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-329-081 in 1 CARTON
124 in 1 BLISTER PACK
2NDC:55315-329-071 in 1 CARTON
236 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/02/1990
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(55315-329)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(55315-329)

Revised: 11/2012
Document Id: f8c123bd-51fe-4620-94e1-fec87abe7761
Set id: 64914bb8-5b37-43a0-940f-68b985ace171
Version: 2
Effective Time: 20121114
 
FRED'S, INC.