Allergy Relief by Freds Inc DRUG FACTS

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Freds Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALLERGY RELIEF ANTIHISTAMINE- diphenhydramine hcl 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:

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

temporarily relieves these symptoms due to the common cold:

• runny nose
• sneezing 

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

• 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 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

• store at 59° to 77°F in a dry place. Protect from heat, humidity and light

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:

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

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

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

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 GLYCOL, UNSPECIFIED (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	04/08/2013	04/08/2020
1		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	04/08/2013	04/08/2020

Labeler - Freds Inc (005866116)

Revised: 6/2019

Document Id: 7b51e318-5f6f-4a73-9e50-7a3bfba23ca2

34390-5

Set id: 70dab7f5-c1f1-4082-8518-d93dbb540348

Version: 2

Effective Time: 20190625

 

Freds Inc