ALLERGY RELIEF ANTIHISTAMINE- diphenhydramine hydrochloride capsule, liquid filled 
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 capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

temporarily relieves these symptoms due to the common cold:

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask a doctor before use if you have

  • glaucoma

  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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  take 1 or 2 capsules 
children 6 to under 12 years of age  take 1 capsule
children under 6 years of age  do not use

Other information

Inactive ingredients

edible dye free ink, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution.

Questions or comments?

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

Principal Display Panel

*Compare to the Active Ingredient of Benadryl® Liqui-Gels®

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl®, or Catalent Pharma solutions, Inc., owner of the registered trademark Liqui-Gels®.

Dye- Free

Allergy Relief

Diphenhydramine HCl 25 mg/ Antihistamine

Relieves:

Softgels**

(**Liquid-Filled Capsules)

PRODUCT OF CANADA

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Product Label

Freds Inc

Diphenhydramine HCl 25 mg capsules

ALLERGY RELIEF  ANTIHISTAMINE
diphenhydramine hcl capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-721
Route of Administration ORAL DEA Schedule     
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
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
Color WHITE, YELLOW Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code A33
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55315-721-24 2 in 1 CARTON
1 12 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 04/08/2013
Labeler - Freds Inc (005866116)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 4/2013
Document Id: 71c993e5-17ba-4f90-a936-b95ecc367230
Set id: 70dab7f5-c1f1-4082-8518-d93dbb540348
Version: 1
Effective Time: 20130425
 
Freds Inc