Label: DIPHENHYDRAMINE HYDROCHLORIDE tablet
- NDC Code(s): 17714-135-01
- Packager: Advance Pharmaceutical Inc.
- 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 December 22, 2017
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- Active Ingredient
- Purpose
- Uses
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Warnings
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.
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
- Questions or Comments
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17714-135 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 27 (UNII: 2LRS185U6K) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink Score no score Shape CAPSULE Size 11mm Flavor Imprint Code AP;135 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17714-135-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/26/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/26/2006 Labeler - Advance Pharmaceutical Inc. (078301063) Registrant - Advance Pharmaceutical Inc. (078301063) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical Inc. 078301063 manufacture(17714-135)