Label: DIPHENHYDRAMINE HYDROCHLORIDE liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-1227-0, 54868-1227-2 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0182-6168
- Category: HUMAN OTC DRUG LABEL
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
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each teaspoon (5 mL))
- 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
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- Directions
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-1227(NDC:0182-6168) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine 12.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength citric acid monohydrate (UNII: 2968PHW8QP) D&C Red no. 33 (UNII: 9DBA0SBB0L) FD&C Red no. 40 (UNII: WZB9127XOA) glycerin (UNII: PDC6A3C0OX) polysorbate 20 (UNII: 7T1F30V5YH) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) sodium citrate (UNII: 1Q73Q2JULR) sorbitol (UNII: 506T60A25R) Product Characteristics Color PINK Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-1227-0 473 mL in 1 BOTTLE, PLASTIC 2 NDC:54868-1227-2 118 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/22/2002 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel