Label: ALLERGY RELIEF- diphenhydraime hcl tablet, film coated
- NDC Code(s): 68210-4169-3
- Packager: Spirit Pharmaceuticals 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 November 16, 2021
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- Drug Facts
- Purpose
- Active Ingredient
- Uses
- Warnings
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
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- Pouch Label
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
diphenhydraime hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4169 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DICALCIUM CITRATE (UNII: LGH2B6RC26) D&C RED NO. 27 (UNII: 2LRS185U6K) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink Score no score Shape CAPSULE Size 11mm Flavor Imprint Code S4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-4169-3 30 in 1 POUCH; Type 0: Not a Combination Product 11/16/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/16/2021 Labeler - Spirit Pharmaceuticals LLC (179621011) Registrant - Spirit Pharmaceuticals LLC (179621011) Establishment Name Address ID/FEI Business Operations Elysium Pharmaceuticals Ltd 915664486 manufacture(68210-4169)