Q-dryl Allergy

Drug Labeling and Warnings

Drug Details [pdf]

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.

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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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

QDRYL ALLERGY 
diphenhydramine hydrochloride solution

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/01/1997	10/31/2019

Labeler - Qualitest Pharmaceuticals (011103059)

Revised: 12/2018

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

34390-5

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

Version: 8

Effective Time: 20181203