NDC | 11822-0386-2, 11822-0386-7 |
Set ID | 99883c0a-4152-440e-b626-4af6ed07a2ff |
Category | HUMAN OTC DRUG LABEL |
Packager | Rite Aid Corporation |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | ANDA040564 |
- Active ingredient (in each tablet)
- Purpose
- Use
-
Warnings
Ask a doctor before use if you have
- glaucoma
- a breathing problem such as asthma, emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
RITE
AID
PHARMACY®*Compare to the active ingredient
in Unisom® Sleep Tabs®sleep aid
doxylamine succinate 25 mg
nighttime sleep aidhelps to reduce
difficulty falling asleepsafe & effective
go to sleep fast!
just one tablet per dose
easy to swallow
actual size
easy to swallow48 TABLETS
TAMPER EVIDENT: DO NOT USE IF
CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING*This product is not manufactured or distributed by Chattem,
Inc., owner of the registered trademark Unisom®
SleepTabs®.
50844 REV0513A38622DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.
Rite Aid 44-386
-
INGREDIENTS AND APPEARANCE
SLEEP AID
doxylamine succinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0386 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 25 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color BLUE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 44;386 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0386-2 6 in 1 CARTON 04/11/2002 08/01/2022 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:11822-0386-7 4 in 1 CARTON 04/11/2002 11/30/2017 2 8 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 ANDA ANDA040564 04/11/2002 08/01/2022 Labeler - Rite Aid Corporation (014578892) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(11822-0386) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(11822-0386) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(11822-0386) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(11822-0386) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(11822-0386)