Label: SLEEP AID- doxylamine succinate tablet
- NDC Code(s): 41250-986-22
- Packager: Meijer Distribution Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 30, 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
-
Warnings
Do not use
- in children under 12 years of age
- with any other product containing doxylamine
- unless you have time for a full night’s sleep
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 any other sleep-aid
- tranquilizers
- any other antihistamines
- any other drugs
When using this product
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
- take only at bedtime
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
NDC 41250-986-22
Compare to
Unisom® SleepTabs®
active ingredient*Meijer®
sleep aid
Doxylamine succinate | 25 mg | Nighttime Sleep-Aid
Helps to Reduce Difficulty Falling Asleep
One Tablet Per Dose48 Tablets
Actual
SizeTAMPER 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 REV0123E38622DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.comMeijer 44-386
-
INGREDIENTS AND APPEARANCE
SLEEP AID
doxylamine succinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-986 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:41250-986-22 3 in 1 CARTON 05/06/2019 1 16 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 05/06/2019 Labeler - Meijer Distribution Inc (006959555) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(41250-986) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(41250-986) , pack(41250-986) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(41250-986) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(41250-986)