Label: DYE FREE CHILDRENS DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride liquid
- NDC Code(s): 68094-024-59, 68094-024-62
- Packager: Precision Dose, Inc.
- This is a repackaged label.
- Source NDC Code(s): 49580-0293
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 12, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL )
- Purpose
- Uses
-
Warnings
Do not use
- with any other product containing diphenhydramine, even one used on the skin
- to make a child sleepy
Ask a doctor before use if the child has
- a breathing problem such as chronic bronchitis
- glaucoma
- a sodium-restricted diet
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- How Supplied
- QUESTIONS
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 10 mL Cup Label
NDC 68094-024-59
PrecisionDose™
Children's DYE FREE
diphenhydrAMINE HCl Liquid
25 mg/10 mLDelivers 10 mL, each 5 mL contains: sodium 8 mg
Alcohol Free, Protect from light, Hospital Use OnlyStore between 20°-25°C (68°-77°F)
Do not refrigerate
Pkg. By: Precision Dose, Inc.
South Beloit, IL 61080
1158 R0 -
INGREDIENTS AND APPEARANCE
DYE FREE CHILDRENS DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-024(NDC:49580-0293) 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) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68094-024-62 3 in 1 CASE 12/27/2018 10/31/2024 1 10 in 1 TRAY 1 NDC:68094-024-59 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M012 12/27/2018 10/31/2024 Labeler - Precision Dose, Inc. (035886746)