Allergy Relief: Package Insert and Label Information

ALLERGY RELIEF- diphenhydramine hydrochloride capsule, liquid filled
PuraCap Pharmaceutical LLC

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 softgel)

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

  • 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
  • g laucoma
  • 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 right away (1-800-222-1222).

Directions

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours

adults and children 12 years and over

1 to 2 softgels

children 6 to under 12 years

1 softgel

children under 6 years

do not use this product in children under 6 years of age

Other information

  • store at room temperature 15°-30°C (59°-86°F) in a dry place. Protect from heat, humidity, and light.
  • do not use if carton is open or blister unit is broken

Inactive ingredients

gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution and white edible ink

Questions or comments?

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Allergy Relief

Diphenhydramine HCl 25 mg 24 softgels

NDC 51013-199-04

*Compare to the active ingredient in Benadryl® Dye-Free Allergy Liqui-Gels®

Carton Label
(click image for full-size original)
ALLERGY RELIEF
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51013-199
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
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
WATER
SORBITOL
SORBITAN
Product Characteristics
Color yellow (clear natural) Score no score
Shape capsule (oblong) Size 15mm
Flavor Imprint Code PC4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51013-199-04 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 (51013-199-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/14/2017
Labeler — PuraCap Pharmaceutical LLC (962106329)
Establishment
Name Address ID/FEI Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. 421293287 manufacture (51013-199), analysis (51013-199)

Revised: 01/2020 PuraCap Pharmaceutical LLC

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