ALLERGY RELIEF- diphenhydramine hcl liquid

Allergy Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredient (in each 5 mL tsp)

Diphenhydramine HCL, 12.5 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

a breathing problem such as emphysema or chronic bronchitis

glaucoma

trouble urinating due to the enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product:

excitability might occur, especially in children

marked drowsiness may occur  avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness effect

be careful when driving a motor vehicle or operating machinery

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, or as directed by doctor.
Do not exceed recommended dose.

• Adults and Children 12 years of age and over: take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours
• Children 6 to under 12 years of age: take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours
• Children under 6 years of age: consult a doctor

Other information

Store at controlled room temperature 15°-30°C (59°-86°F).

Do not refrigerate. Avoid excessive heat or humidity.

Protect from light. 

Inactive ingredients

Cherry flavor, citric acid, FD&C Red #40, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, and sucralose

Questions or comments?

Call weekdays from 8 AM to 4 PM AST at 1-787-767-2072 | www.kramernovis.com

Manufactured in the USA for Kramer Novis, San Juan, PR 00917

SPL UNCLASSIFIED SECTION

Compare to the active ingredient of Benadryl®  Allergy Liquid*

Relieves:

√  Runny Nose

√  Sneezing

√  Itchy, Watery Eyes

√  Itchy Throat

Cherry Flavor

Alcohol Free

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS TORN, BROKEN OR MISSING.

Packaging

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-665
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-665-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/02/2020

Labeler - KRAMER NOVIS (090158395)