Label: DIPHENHYDRAMINE HCL capsule
- NDC Code(s): 71399-8026-1, 71399-8026-2
- Packager: Akron Pharma Inc.
- 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.
Drug Label Information
Updated February 26, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each banded capsule)
- Purpose
- Uses
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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 you have
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HCL
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71399-8026 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GELATIN (UNII: 2G86QN327L) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) Product Characteristics Color pink (light pink) Score no score Shape capsule Size 18mm Flavor Imprint Code AP;26 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71399-8026-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2021 2 NDC:71399-8026-2 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 01/15/2021 Labeler - Akron Pharma Inc. (067878881)