Label: CHILDRENS BENADRYL DYE-FREE ALLERGY- diphenhydramine hydrochloride solution
- NDC Code(s): 50580-535-01, 50580-535-08
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 1, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- Purpose
- Uses
- Warnings
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Directions
- 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?
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PRINCIPAL DISPLAY PANEL
NDC 50580-535-01
Children's
Benadryl ®DYE-FREE ALLERGY
Diphenhydramine HCl/antihistamine
12.5 mg/5 mL oral solution4-6 Hours/Dose
RELIEF OF:
- Runny Nose
- Sneezing
- Itchy,Watery Eyes
- Itchy Throat or Nose
✔ Free Of:
- Dyes
- Alcohol
- Sugar
- Parabens
- High Fructose
Corn Syrup
Bubble Gum!
Flavored Liquid4 fl oz (118 mL)
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INGREDIENTS AND APPEARANCE
CHILDRENS BENADRYL DYE-FREE ALLERGY
diphenhydramine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-535 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) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL SOLUTION (UNII: 8KW3E207O2) Product Characteristics Color white (Clear, colorless) Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-535-01 1 in 1 CARTON 12/01/2015 1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 2 NDC:50580-535-08 1 in 1 CARTON 06/16/2022 2 236 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 Drug M012 07/01/2008 Labeler - Johnson & Johnson Consumer Inc. (878046358)