Label: DIPHENHYDRAMINE HCL 25 MG- diphenhydramine hcl capsule
- NDC Code(s): 69618-024-01
- Packager: Reliable 1 Laboratories LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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Drug Label Information
Updated March 29, 2023
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- Active ingredient (in each capsule)
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- WHEN USING
- PREGNANCY OR BREAST FEEDING
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- Inactive ingredients
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HCL 25 MG
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69618-024 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 D&C RED NO. 28 (UNII: 767IP0Y5NH) METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM LAURYL SULFATE (UNII: 368GB5141J) GELATIN (UNII: 2G86QN327L) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLPARABEN (UNII: Z8IX2SC1OH) BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYLPARABEN (UNII: 3QPI1U3FV8) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color pink (Half pink and half white) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code AP;20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69618-024-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/01/2015 Labeler - Reliable 1 Laboratories LLC (079718111) Registrant - Reliable 1 Laboratories LLC (079718111)