PUREGEN LABS ALLERGY RELIEF- diphenhydramine hcl liquid

Puregen Labs Allergy Relief by

Drug Labeling and Warnings

Puregen Labs Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Advanced Rx LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each 5 mL teaspoonful)

Diphenhydramine HCl 12.5 mg

PURPOSE

Purpose

Antihistamine

INDICATIONS & USAGE

Uses

• Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes

WARNINGS

Warnings

Do not use

• with any other product conatining diphenhydramine, including one used on the skin
• to make a child sleepy

Ask a doctor before use if you have

• a breathing problem such as chronic bronchitis
• glaucoma

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers.

When using this product

• do not exceed recommended dose
• excitability may occur, especially in children
• marked drowsiness may occur
• sedatives, and tranquilizers may increase drowsiness

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• take every 4 to 6 hours as needed, or as directed by a doctor
• do not take more than 6 doses in 24 hours
• use dosing cup provided.

• Age: Dosage
• Children 6 to 11 years: 5 mL to 10 mL
• Children2 to 5 years: Do not use unless directed by a doctor
• Children under 2 years: Do not use

INACTIVE INGREDIENT

Inactive ingredients: Artificial and natural cherry flavor, citric acid, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose and sucrose.

QUESTIONS

Questions or comments? 1-800-630-8895

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PUREGEN LABS ALLERGY RELIEF 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-201
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-201-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/01/2024

Labeler - Advanced Rx LLC (042795108)