Your browser does not support JavaScript! QDRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [QUALITEST PHARMACEUTICALS]
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QDRYL ALLERGY (diphenhydramine hydrochloride) solution
[Qualitest Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 yearsdo 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. 5/10 R6
8273205  0823

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

This is an image of the label for Q-dryl Allergy.
QDRYL ALLERGY 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0603-0823
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C RED NO. 40 
GLYCERIN 
POLOXAMER 407 
POLYSORBATE 20 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SODIUM CITRATE 
SUCROSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-0823-541 in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC
2NDC:0603-0823-81237 mL in 1 BOTTLE, PLASTIC
3NDC:0603-0823-94118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/01/1997
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE

Revised: 6/2010
 
Qualitest Pharmaceuticals

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