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Allergy Relief by Freds Inc

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Freds Inc
NDC Code: 55315-483

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.

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:
    • sneezing
    • itchy, watery eyes
    • runny nose
    • itching of the nose or throat

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

  • 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
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
  • swallow whole, do not crush, chew, or dissolve
 adults and children 12 years of age and over take 1 to 2 capsules 
 children 6 to under 12 years of age take 1 capsule
children under 6 years of age do not use

Other information
  • store between 15-30ºC (59-86ºF)
  • protect from light, heat and humidity

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 in Benadryl® Liqui-Gels®*

Antihistamine

Allergy Relief

Diphenhydramine HCl 25 mg

Allergy Relief

Sneezing, itchy, watery eyes, runny nose, itchy thorat

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

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

Diphenhydramine HCl 25 mg

ALLERGY RELIEF 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-483
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
SORBITOL 
SORBITAN 
Product Characteristics
ColorYELLOW (clear) Scoreno score
ShapeCAPSULESize15mm
FlavorImprint CodeA33;SCU
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-483-242 BLISTER PACK in 1 BOX
112 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33612/18/2015
Labeler - Freds Inc (005866116)
Registrant - P & L Development, LLC (800014821)

Revised: 12/2015
 
Freds 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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