Label: CAREALL DIPHENHYDRAMINE- diphenhydramine hydrochloride tablet, coated
- NDC Code(s): 51824-056-01
- Packager: New World Imports, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 11, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Keep out of reach of children
- Uses
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Warnings
Do not use with any other products containing diphenhydramine, including ones 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
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product:
Marked drowsiness may occur
Avoid alcoholic beverages
Alcohol, sedatives, and 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
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAREALL DIPHENHYDRAMINE
diphenhydramine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-056 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 ALUMINUM LAKE (UNII: ZK64F7XSTX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) Magnesium Stearate (UNII: 70097M6I30) Cellulose, Microcrystalline (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Silicon Dioxide (UNII: ETJ7Z6XBU4) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color pink (Bright Pink) Score no score Shape OVAL (Oval in Shape, sides straight, top and bottom rounded) Size 11mm Flavor Imprint Code 048;D Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-056-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/28/2016 12/01/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/28/2016 12/01/2026 Labeler - New World Imports, Inc (075372276)