Label: DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hcl capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 76413-306-24 - Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 0904-2035
- 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 March 22, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each banded capsule)
- 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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton Label
CommUnityCare Federally Qualified Health Centers
DIPHENHYDRAMINE
25mg/24 CapsDate:
Name:
Dr.USE AS DIRECTED.
123456
1/1/01
DIPHENHYDRAMINE 25mg/24 CAPS NDC 76413-306-24
Batch: 123456
Lot: 123456
Exp: 1/1/01
MAJORFederal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-306(NDC:0904-2035) 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 BUTYLPARABEN (UNII: 3QPI1U3FV8) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Product Characteristics Color PINK Score no score Shape CAPSULE Size 14mm Flavor Imprint Code 44;107 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76413-306-24 2 in 1 CARTON 03/15/1990 1 12 in 1 BLISTER PACK; 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 03/15/1990 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 REPACK(76413-306) , RELABEL(76413-306)