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Allergy by FRED'S, INC.

Medically reviewed on January 29, 2018

Dosage form: tablet, coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: FRED'S, INC.
NDC Code: 55315-329

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 (in each tablet)

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
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the 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 beverages

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • use caution 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 (1-800-222-1222) right away.

Directions
  • take every 4 to 6 hours, or as directed by a doctor

  • do not take more than 6 times in 24 hours

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
  • each tablet contains: calcium 30 mg

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

  • protect from moisture

  • see end flap for expiration date and lot number

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

Questions or comments?

1-800-426-9391

Principal Display Panel

fred's
pharmacy

55315-329-08

ACTUAL SIZE

ALLERGY RELIEF
Diphenhydramine HCl 25 mg - Antihistamine

Relieves:

  • Sneezing 
  • Itchy Throat
  • Runny Nose
  • Itchy, Watery Eyes    

24 TABLETS 

Compare to the active Ingredient in:
Benadryl® Allergy ULTRATAB® Tablets*

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

100% satisfaction guranteed
Questions or comments: 1-855-331-FRED (3733)

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy ULTRATAB® Tablets.
50844      REV1016G32908

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


Freds 44-329

ALLERGY 
diphenhydramine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem 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 
MAGNESIUM STEARATE 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
STARCH, CORN 
TALC 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize11mm
FlavorImprint Code44;329
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-329-082 BLISTER PACK in 1 CARTON
112 TABLET, COATED in 1 BLISTER PACK
2NDC:55315-329-073 BLISTER PACK in 1 CARTON
212 TABLET, COATED 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/FEIOperations
LNK International, Inc.038154464PACK(55315-329)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(55315-329)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(55315-329), PACK(55315-329)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(55315-329)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(55315-329)

 
FRED'S, INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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