Label: QDRYL ALLERGY- diphenhydramine hydrochloride solution
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Contains inactivated NDC Code(s)
NDC Code(s): 17856-1823-1 - Packager: ATLANTIC BIOLOGICALS CORP
- This is a repackaged label.
- Source NDC Code(s): 0603-0823
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 7, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL = 1 tsp)
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use if you have
- ASK DOCTOR/PHARMACIST
- When using this product
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
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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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
QDRYL ALLERGY
diphenhydramine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-1823(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:17856-1823-1 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 09/28/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 12/01/1997 Labeler - ATLANTIC BIOLOGICALS CORP (047437707) Establishment Name Address ID/FEI Business Operations ATLANTIC BIOLOGICALS CORP 047437707 repack(17856-1823) , relabel(17856-1823)