Label: DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML solution
- NDC Code(s): 82568-0016-4, 82568-0016-6, 82568-0016-8
- Packager: AARNA USA INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 30, 2025
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- ACTIVE INGREDIENT
- PURPOSE
- WHEN USING
-
WARNINGS
Warnings
Do not use
- with any other product containing diphenhydramine, even one used on 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
Ask a doctor or pharmacist before use if the child is
taking sedatives or tranquilizers.
When using this product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitabillty may occur, especially in children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
-
INDICATIONS & USAGE
Directions
- do not take more than 6 doses in any 24 hours
- take every 4 to 6 hours, or as directed by a doctor
- mL = milliliter
- keep dosing cup with product
- find the right dose on the chart below
Age (yr)
Dose (mL)
children 6 to 11 years
5 mL to 10 mL
children 2 to 5 years
Do not use unless directed by a doctor
children under 2 years
Do not use
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML
diphenhydramine hcl 12.5 mg per 5 ml solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82568-0016 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE (UNII: 8GTS82S83M) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE 12.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL SOLUTION (UNII: 8KW3E207O2) SODIUM SACCHARIN (UNII: SB8ZUX40TY) SODIUM CITRATE (UNII: 1Q73Q2JULR) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SUCROSE (UNII: C151H8M554) 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:82568-0016-4 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/14/2025 2 NDC:82568-0016-8 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/14/2025 3 NDC:82568-0016-6 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/14/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/14/2025 Labeler - AARNA USA INC. (118515992)
