ALLERGY RELIEF ANTIHISTAMINE- diphenhydramine hcl tablet 
Freds 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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DRUG FACTS

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
  • sneezing
  • itchy, watery eyes
  • itching nose or throat

temporarily relieves these symptoms of 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

  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you have

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

  • take every 4 to 6 hours, or as directed by a doctor 
  • do not more than 6 doses in 24 hours
 adults and children 12 years and over take 1 to 2 tablets 
 children 6 to under 12 years  take 1 tablet
children under 6 yearsdo not use

Other information

  • each tablet contains: calcium 25 mg
  • store between 20-25°C (68-77°F)
  • protect from light and moisture

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesiun stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, titanium dioxide.

*contains one or more of these ingredients

Questions or Comments?

Call 1-877-753-3935 Monday- Friday 9AM-5PM EST

Principal Display Panel

 ALLERGY RELIEF

Diphenhydramine HCl 25 mg-Antihistamine

Relieves:

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

Compare To The Active Ingredient in Benadryl® Allergy**

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL, RD, MEMPHIS, TN 38118

www.fredsinc.com

Product Label

Diphenhydramine HCI 25 mg

Fred's Pharmacy Allergy Relief

ALLERGY RELIEF  ANTIHISTAMINE
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-690
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code T61;V25;S4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-690-011 in 1 BOX07/22/201001/26/2024
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33607/22/201001/26/2024
Labeler - Freds Inc (005866116)

Revised: 10/2021
Document Id: 1ff4450a-eecc-420e-ab3d-9b4abb8bd4f1
Set id: 27b19a08-0b3f-4fba-8b2d-1258dbf566cf
Version: 5
Effective Time: 20211019
 
Freds Inc