QDRYL ALLERGY- diphenhydramine hydrochloride solution
Qualitest Pharmaceuticals

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.

----------

Q-dryl Allergy

Active ingredient (in each 5 mL = 1 tsp)

Diphenhydramine HCl 12.5 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

glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

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

use an accurate measuring device to administer this medication
take every 4 to 6 hours

children under 2 years	do not use
children 2 to 5 years	ask a doctor
children 6 years to under 12 years	5 mL (1 tsp) to 10 mL (2 tsp); not more than 60 mL (12 tsp) in 24 hours
adults and children 12 years and over	10 mL (2 tsp) to 20 mL (4 tsp); not more than 120 mL (24 tsp) in 24 hours

Other information

each tsp contains: sodium 5 mg
store at 15°- 30°C (59°- 86°F)
protect from freezing

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

citric acid, D&C red #33, FD&C red #40, flavor, glycerin, poloxamer 407, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 3/15 R7
8273205 0823

PRINCIPAL DISPLAY PANEL

This is an image of the carton for Q-dryl Allergy.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

This is the label for Q-dryl 1 Pint (473mL)

QDRYL ALLERGY
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0603-0823
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0603-0823-54	1 in 1 CARTON	12/01/1997	10/31/2019
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:0603-0823-58	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/1997	10/31/2019
3	NDC:0603-0823-81	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/1997	10/31/2019
4	NDC:0603-0823-94	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/1997	10/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	12/01/1997	10/31/2019

Labeler - Qualitest Pharmaceuticals (011103059)

Revised: 12/2018

Document Id: 0a9f7b02-7171-43d1-8f84-cce70a2c071b

Set id: b808660f-83ef-4c24-b459-d709f0f64b68

Version: 8

Effective Time: 20181203

Qualitest Pharmaceuticals