Label: ALLERGY- diphenhydramine hcl solution
- NDC Code(s): 37808-379-26
- Packager: H E B
- 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 June 14, 2018
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)
- Purpose
- Uses
-
Warnings
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
- •
- glaucoma
- •
- a sodium-restricted diet
-
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?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
ALLERGY
diphenhydramine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-379 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) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLOXAMER 407 (UNII: TUF2IVW3M2) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color RED (Bluish-Red) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-379-26 1 in 1 CARTON 07/15/1987 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/15/1987 Labeler - H E B (007924756)