QDRYL ALLERGY- diphenhydramine hydrochloride solution 
REMEDYREPACK INC.

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

OTC - ACTIVE INGREDIENT

Diphenhydramine HCl     12.5 mg

 

OTC - PURPOSE

Antihistamine

 

INDICATIONS & USAGE

  • 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



OTC - DO NOT USE

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

 

OTC - ASK DOCTOR

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

 

OTC - ASK DOCTOR/PHARMACIST

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

 

OTC - WHEN USING

  • 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

 

OTC - PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

 

OTC - 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)

 

DOSAGE & ADMINISTRATION

  • 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

 

SPL UNCLASSIFIED

  • 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 INGREDIENT

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

 

SPL UNCLASSIFIED

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 5/10 R6
8273205  0823

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Qdryl Allergy


GENERIC: Diphenhydramine Hydrochloride


DOSAGE: SOLUTION


ADMINSTRATION: ORAL


NDC: 61786-153-45


ACTIVE INGREDIENT(S):

  • DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL


INACTIVE INGREDIENT(S):

  • ANHYDROUS CITRIC ACID
  • SACCHARIN SODIUM
  • SODIUM BENZOATE
  • SODIUM CITRATE
  • WATER
  • POLYSORBATE 20
  • D&C RED NO. 33
  • FD&C RED NO. 40
  • POLOXAMER 407
  • GLYCERIN
  • SUCROSE


PACKAGING: 118 mL in 1 BOTTLE, PLASTIC




MM1

MM2

QDRYL ALLERGY 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61786-153(NDC:0603-0823)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61786-153-45118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/16/201501/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/16/201501/16/2016
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2017
 
REMEDYREPACK INC.