Label: CHILDRENS BENADRYL ALLERGY- diphenhydramine hydrochloride solution
- NDC Code(s): 50580-534-04, 50580-534-08, 50580-534-16
- Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Category: HUMAN OTC DRUG LABEL
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.
Updated November 19, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
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 the child has
- a breathing problem such as chronic bronchitis
- a sodium-restricted diet
When using this product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
- find right dose on chart below
- mL = milliliter
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
Age (yr) Dose (mL) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL to 10 mL
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
CHILDRENS BENADRYL ALLERGY
diphenhydramine hydrochloride solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-534 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) ammonium glycyrrhizate (UNII: 3VRD35U26C) poloxamer 407 (UNII: TUF2IVW3M2) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sodium chloride (UNII: 451W47IQ8X) sodium citrate, unspecified form (UNII: 1Q73Q2JULR) sucrose (UNII: C151H8M554) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-534-04 1 in 1 CARTON 07/01/2008 1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 2 NDC:50580-534-08 1 in 1 CARTON 07/01/2008 2 236 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 3 NDC:50580-534-16 2 in 1 PACKAGE 01/28/2009 3 1 in 1 CARTON 3 236 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/01/2008 Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)