DYE-FREE ALLERGY- diphenhydramine hydrochloride solution

Dye-Free ALLERGY by

Drug Labeling and Warnings

Dye-Free ALLERGY by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc., Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient [in each 10 mL]

Diphenhydramine HCl, USP 25 mg

Purpose

Antihistamine

Uses

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

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 chronic bronchitis
• glaucoma
• a sodium-restricted diet
• trouble urinating due to enlarged prostate

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
• 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, or as directed by a doctor
• do not take more than 6 doses in 24 hours
• mL = milliliter

• Age (yr): Dose (mL)
• Adult and children 12 years and older: 10 mL to 20 mL
• Children under 12 years: Consult a doctor

Attention:   use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

• each 10 mL contains: sodium 28 mg
• store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used
• see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, flavor, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

Questions or Comments?

1-855-274-4122

DO NOT USE IF SEAL UNDER CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in the U.S.A
V-31735

CVS® Quality
Money Back Guarantee

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)

CVS
HealthTM                                                                                          

Dry Free Liquid

NDC: 59779-184-24

Allergy
Relief
LIQUID MEDICATION
DIPHENHYDRAMINE HCl 
25 mg/10 mL
ORAL SOLUTION
Antihistamine

Relieves:

• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy throat

Cherry Flavor

Alcohol Free

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

DYE-FREE ALLERGY 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-184
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CHERRY (UNII: BUC5I9595W)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	YELLOW (colorless to pale yellow)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-184-24	1 in 1 CARTON	11/26/2014
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	11/26/2014

Labeler - CVS Pharmacy, Inc. (062312574)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(59779-184)