Label: NIGHTTIME SLEEP AID- doxylamine succinate tablet
- NDC Code(s): 21130-386-27
- Packager: Safeway
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each tablet)
Doxylamine succinate 25 mgClose
helps to reduce difficulty in falling asleepClose
Ask a doctor before use if you have
- a breathing problem such as asthma, emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- adults: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
- do not give to children under 12 years of age
- Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at controlled room temperature 20º-25ºC (68º-77ºF) [See USP]
- see end flap for expiration date and lot number
- Inactive ingredients
dicalcium phosphate, FD&C blue #1 aluminum lake, magnesiums stearate, microcrystalline cellulose, sodium starch glycolateClose
- Questions or comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-FridayClose
- Principal display panel
Compare to Unisom® SleepTabs® active ingredient*
Doxylamine Succinate Tablets, 5 mg
• Safe. Proven Effective.
• Contains No Pain Reliever
• Just One Tablet Per Dose
*this product is not manufactured or distributed by Chattem, Inc., distributors of the registered trademark Unisom® SleepTabs®.
DISTRIBUTED BY SAFEWAY INC., P.O. BOX 99, PLEASANTON, CA 94566-009
1-888-SAFEWAY / www.safeway.com
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
- INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP AID
doxylamine succinate tablet
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:21130-386 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 25 mg Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C BLUE NO. 1 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO Product Characteristics Color BLUE Score 2 pieces Shape CAPSULE Size 10mm Flavor Imprint Code 33;386 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-386-27 4 in 1 CARTON 1 8 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040564 04/11/2002 Labeler - Safeway (009137209) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(21130-386) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(21130-386)