ALLERGY- diphenhydramine hcl tablet, coated 
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.

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Freds 44-329

Active ingredient (in each tablet)

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 and over

 1 to 2 tablets 
 children 6 to under 12
years
 1 tablet   
 children under 6 years    
 do not use

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 Relief
Antihistamine

Diphenhydramine HCl

Relieves
Sneezing                  
Runny Nose
Itchy, Watery Eyes    
Itchy Throat

24 Tablets - 25 mg Each

Compare to the active Ingredient in: Benadryl® Allergy Ultratab®*

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy Ultratab®.
50844      REV0512F32908

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com
Freds 44-329

Freds 44-329

ALLERGY 
diphenhydramine hcl tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-329
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color PINK Score no score
Shape OVAL Size 11mm
Flavor Imprint Code 44;329
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55315-329-08 2 in 1 CARTON
1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:55315-329-07 3 in 1 CARTON
2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 03/02/1990
Labeler - FRED'S, INC. (005866116)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(55315-329)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(55315-329)

Revised: 2/2016
Document Id: fa486305-b944-481a-82b7-b95319e21d3e
Set id: 64914bb8-5b37-43a0-940f-68b985ace171
Version: 3
Effective Time: 20160223
 
FRED'S, INC.