Label: SLEEP AID- doxylamine succinate tablet
- NDC Code(s): 11822-9386-2, 11822-9386-6
- Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 18, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Use
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Warnings
Ask a doctor before use if you have
- a breathing problem such as asthma, emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- glaucoma
- a breathing problem such as asthma, emphysema or chronic bronchitis
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
NDC 11822-9386-6
Compare to the active ingredient in Unisom® SleepTabs®*
SLEEP-AID
DOXYLAMINE SUCCINATE 25 mg
nighttime sleep-aid
helps to reduce difficulty falling asleepACTUAL SIZE
48
TABLETS
ONE TABLET PER DOSETAMPER EVIDENT: DO NOT USE IF PACKAGE 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 REV1120C38622DISTRIBUTED BY: RITE AID
30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.comSATISFACTION GUARANTEED
If you're not satisfied, we'll
happily refund your money.Rite Aid 44-386
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INGREDIENTS AND APPEARANCE
SLEEP AID
doxylamine succinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-9386 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 DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color blue Score no score Shape OVAL Size 10mm Flavor Imprint Code 44;386 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-9386-2 3 in 1 CARTON 07/30/2019 09/21/2024 1 16 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:11822-9386-6 1 in 1 CARTON 07/30/2019 09/21/2024 2 96 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040564 07/30/2019 09/21/2024 Labeler - Rite Aid Corporation (014578892) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(11822-9386) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(11822-9386) , pack(11822-9386) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(11822-9386) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(11822-9386)