Label: DIPHENHYDRAMINE HCL capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-0026-0, 54868-0026-1, 54868-0026-4, 54868-0026-5, view more54868-0026-6, 54868-0026-7, 54868-0026-8 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 66424-020
- 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 June 5, 2012
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 capsule)
- Uses:
- Warnings:
- Do not use
- Ask a doctor or pharmacist before use
- When using this product
- If pregnant or breast-feeding,
- Keep out of reach of children
- Directions:
- Other information:
- Inactive ingredients:
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HOW SUPPLIED
Diphenhydramine HCL 25 mg Capsules
Bottles of 10
NDC 54868-0026-5
Bottles of 20
NDC 54868-0026-6
Bottles of 30
NDC 54868-0026-1
Bottles of 60
NDC 54868-0026-7
Bottles of 90
NDC 54868-0026-8
Bottles of 100
NDC 54868-0026-0
Bottles of 1000
NDC 54868-0026-4
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HCL
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-0026(NDC:66424-020) 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color pink Score no score Shape CAPSULE Size 14mm Flavor Imprint Code PH014 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-0026-0 100 in 1 BOTTLE, PLASTIC 2 NDC:54868-0026-1 30 in 1 BOTTLE, PLASTIC 3 NDC:54868-0026-4 1000 in 1 BOTTLE, PLASTIC 4 NDC:54868-0026-5 10 in 1 BOTTLE, PLASTIC 5 NDC:54868-0026-6 20 in 1 BOTTLE, PLASTIC 6 NDC:54868-0026-7 60 in 1 BOTTLE, PLASTIC 7 NDC:54868-0026-8 90 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/27/2010 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel, repack