Label: DIPHENHYDRAMINE HYDROCHLORIDE 25MG tablet
- NDC Code(s): 70692-148-01, 70692-148-46
- Packager: Strive Pharmaceuticals Inc
- 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 April 18, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Do not use
• to make a child sleepy
• with other products containing diphenhydramine, even ones used on skinAsk a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in childrenIf pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
RIGHT REMEDIES
Compare to the active ingredient of Benadryl® Allergy Ultratabs®*
Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816
Product of India
Packaged & Quality Assured in USA
REV.00-102022
READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Benadryl® Allergy Ultratabs®
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE
- Packaging
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE 25MG
diphenhydramine hydrochloride 25mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70692-148 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) MAGNESIUM STEARATE (UNII: 70097M6I30) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) D&C RED NO. 27 (UNII: 2LRS185U6K) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) Product Characteristics Color pink Score no score Shape CAPSULE Size 12mm Flavor Imprint Code DP Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70692-148-01 100 in 1 PACKAGE; Type 0: Not a Combination Product 12/28/2018 2 NDC:70692-148-46 1 in 1 CARTON 04/06/2023 2 72 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 12/20/2018 Labeler - Strive Pharmaceuticals Inc (080028013)