OTC Medication Information: Allergy Relief Dye-Free

ALLERGY RELIEF DYE-FREE- diphenhydramine hydrochloride capsule, liquid filled
Harmon Store 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.

Active ingredient (in each liquid-filled capsule)

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

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged 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 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 (1-800-222-1222) right away.

Directions

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years of age and over 1 to 2 capsules
children 6 to under 12 years of age 1 capsule
children under 6 years of age do not use this product in children under 6 years of age

Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from heat, humidity and light
  • see end flap for expiration date and lot number

Inactive ingredients

edible white ink, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

COREV ALUES™

Compare to active ingredient in
Benadryl® Dye-Free Allergy LIQUI-GELS®

NDC 63940-658-08

Allergy Relief
Diphenhydramine HCl 25 mg
Antihistamine

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

Actual Size

24 Liquid-filled Capsules

Dye-Free

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

†This product is not manufactured or distributed by
McNeil Consumer Healthcare, owner of the registered
trademark Benadryl® Dye-Free Allergy LIQUI-GELS®.
50844 ORG061465808

Distributed by: Liberty Procurement, Inc.,
650 Liberty Ave., Union, NJ 07083 U.S.A.
Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

Product of China
Packaged and Quality Assured in the USA

Core Values 44-658
(click image for full-size original)

Core Values 44-658

ALLERGY RELIEF DYE-FREE diphenhydramine hcl capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-658
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
MINERAL OIL
POLYETHYLENE GLYCOL, UNSPECIFIED
WATER
SORBITOL
GELATIN, UNSPECIFIED
LECITHIN, SOYBEAN
Product Characteristics
Color yellow (clear) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code 658
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63940-658-08 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (63940-658-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/01/2015
Labeler — Harmon Store Inc. (804085293)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 pack (63940-658)

Revised: 07/2021 Harmon Store Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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