NDC | 57896-681-01, 57896-681-10, 57896-681-24 |
Set ID | 9d3419b6-9845-4b6c-a359-05497daacfa3 |
Category | HUMAN OTC DRUG LABEL |
Packager | Geri-Care Pharmaceutical Corp |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART336 |
- Active ingredient (in each tablet)
- Purpose
- Uses
-
Warnings
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, including one used on skin
Ask a doctor before use if you have
- a breathing problem such as chronic bronchitis or emphysema
- trouble urinating due to an enlarged prostate gland
- glaucoma
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- be careful when driving a motor vehicle or operating machinery
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
- package label
-
INGREDIENTS AND APPEARANCE
GERI-DRYL ALLERGY RELIEF
diphenhydramine hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-681 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) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) 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 T;061 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-681-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2012 2 NDC:57896-681-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2012 3 NDC:57896-681-24 1 in 1 CARTON 09/01/2011 3 24 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 part336 09/01/2011 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254) Establishment Name Address ID/FEI Business Operations Geri-Care Pharmaceutical Corp 611196254 repack(57896-681)