Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 61919-078-20, 61919-078-30, 61919-078-90 - Packager: DIRECT RX
- This is a repackaged label.
- Source NDC Code(s): 0603-3339
- 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 August 27, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- INSTRUCTIONS FOR USE SECTION
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WARNINGS SECTION
Do not use 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
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
- you may get very drowsy
- avoid alcoholic drinks
- alcohol, sedatives & tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
If pregnant or breast-feeding, ask a health professional before use.
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- DOSAGE & ADMINISTRATION SECTION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT SECTION
- OTC - QUESTIONS SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61919-078(NDC:0603-3339) 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 BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYLPARABEN (UNII: 3QPI1U3FV8) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color pink Score no score Shape capsule Size 14mm Flavor Imprint Code AP;020 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-078-20 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:61919-078-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:61919-078-30 30 in 1 BOTTLE; 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 01/01/2015 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 relabel(61919-078) , repack(61919-078)
