Label: ALLERGY- diphenhydramine hydrochloride tablet
- NDC Code(s): 76168-121-12
- Packager: Velocity Pharma LLC
- 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 May 14, 2018
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- Official Label (Printer Friendly)
- Active Ingredient
- 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
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
ALLERGY
diphenhydramine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76168-121 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 CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 27 (UNII: 2LRS185U6K) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink Score no score Shape CAPSULE Size 11mm Flavor Imprint Code DP Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76168-121-12 100 in 1 BOTTLE 05/14/2018 1 1 in 1 CARTON; 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 05/14/2018 Labeler - Velocity Pharma LLC (962198409)