Label: SLEEP AID- doxylamine succinate tablet
- NDC Code(s): 70677-0068-1
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 30, 2023
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- 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?
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Principal display panel
sunmark®
*COMPARE TO UNISOM® SLEEPTABS® ACTIVE INGREDIENT
NDC 70677-0068-1
sleep aid
DOXYLAMINE SUCCINATE 25 mg
Nighttime Sleep-AidOne tablet per dose
32 TABLETS
TAMPER 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 REV1120B38627
Distributed by McKesson Corp., via
Strategic Sourcing Services, LLC
Memphis, TN38141
© 2003 McKesson Corporation
www.sunmarkbrand.com
Money Back GuaranteeSunmark 44-386
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INGREDIENTS AND APPEARANCE
SLEEP AID
doxylamine succinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-0068 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:70677-0068-1 2 in 1 CARTON 04/30/2019 03/15/2025 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 04/30/2019 03/15/2025 Labeler - Strategic Sourcing Services LLC (116956644) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(70677-0068) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(70677-0068) , pack(70677-0068) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(70677-0068) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(70677-0068)