ALLERGY RELIEF- diphenhydramine hcl liquid

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION. 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
• itchy nose or throat
• sneezing
• itchy, watery eyes
• Temporarily relieves these symptoms due to the common cold:
• runny nose
• sneezing

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 or emphysema
• trouble urinating due to enlarged prostate gland
• glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• excitability may occur, especially in children
• marked drowsiness may occur
• be careful when driving motor vehicle or operating machinery
• avoid alcoholic drinks
• alcohol, 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

• do not exceed recommended dose
• take every 4 to 6 hours as needed, or as directed by a doctor
• do not take more than 6 doses in 24 hours
• adults and children 12 years and over: 10 to 20 mL (2 to 4 teaspoonful)
• children under 12 years: consult a doctor

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? 1-800-540-3765

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-811
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54859-811-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2019

Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)

Registrant - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)

Establishment
Name	Address	ID/FEI	Business Operations
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION		037342305	manufacture(54859-811)