
USFDA APPLICATION NUMBER - 21393 / DOSAGE - CAPSULE;ORAL - 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE(UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) | DIPHENHYDRAMINE HYDROCHLORIDE | 25mg |
| IBUPROFEN(UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) | IBUPROFEN | 200mg |
Inactive Ingredients
| Ingredient Name | LNK International, Inc. | Haleon US Holdings LLC | L.N.K. International, Inc. | Chain Drug Consortium, LLC | CVS Pharmacy | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | Freds Inc | Good Sense (Geiss, Destin & Dunn, Inc.) | P & L Development, LLC | TARGET Corporation | TOP CARE (Topco Associates LLC) | Walgreen Company | Walgreens |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BUTYL ALCOHOL(8PJ61P6TS3) | |||||||||||||
| D&C RED NO. 33(9DBA0SBB0L) | |||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||||||
| FD&C RED NO. 40(WZB9127XOA) | |||||||||||||
| GELATIN(2G86QN327L) | |||||||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | |||||||||||||
| LECITHIN, SOYBEAN(1DI56QDM62) | |||||||||||||
| MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U) | |||||||||||||
| POLYETHYLENE GLYCOL 600(NL4J9F21N9) | |||||||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||||||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | |||||||||||||
| SHELLAC(46N107B71O) | |||||||||||||
| SORBITAN(6O92ICV9RU) | |||||||||||||
| SORBITOL(506T60A25R) | |||||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | |||||||||||||
| WATER(059QF0KO0R) |