Label: SLEEP AID- doxylamine succinate tablet
- NDC Code(s): 70677-1129-1
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 10, 2024
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- 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
- in children under 12 years of age
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
NDC 70677-1129-1
COMPARE TO UNISOM® SLEEPTABS®
ACTIVE INGREDIENT*Foster & Thrive™
Sleep Aid
Doxylamine succinate tablets, 25 mg
NIGHTTIME SLEEP-AIDOne tablet per dose
ACTUAL SIZE
32 TABLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING©2023 McKesson Corporation
Distributed by: McKesson Corp., via Strategic
Sourcing Services LLC., Memphis, TN 38141
Money Back Guarantee
www.fosterandthrive.com*This product is not manufactured or distributed by Chattem,
Inc., owner of the registered trademark Unisom® SleepTabs®.
50844 ORG012338627 Rev. 04/23Foster and Thrive 44-386
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INGREDIENTS AND APPEARANCE
SLEEP AID
doxylamine succinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1129 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:70677-1129-1 2 in 1 CARTON 05/03/2023 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 05/03/2023 Labeler - Strategic Sourcing Services LLC (116956644) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(70677-1129) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(70677-1129) , pack(70677-1129) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(70677-1129) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(70677-1129)