Label: ALLERGY RELIEF- diphenhydramine hcl tablet
- NDC Code(s): 59726-766-10, 59726-766-40
- Packager: P & L Development, LLC
- 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 March 28, 2023
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 tablet)
- 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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
**Compare to the active ingredient in Benadryl® Allergy Ultratab®
allergy relief
diphenhydramine HCL 25 mg
antihistamine
tablets
**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy Ultratab®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by: PL Developments
200 Hicks Street, Westbury, NY 11590
- Product Label
-
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-766 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 27 (UNII: 2LRS185U6K) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink Score no score Shape CAPSULE Size 11mm Flavor Imprint Code T;061 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59726-766-40 400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/29/2019 11/29/2024 2 NDC:59726-766-10 1 in 1 BOX 11/29/2019 11/29/2024 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 11/29/2019 11/29/2024 Labeler - P & L Development, LLC (800014821)