NDC | 55319-225-12 |
Set ID | 492c9fb5-da6a-4268-afda-3dc4d07c82c0 |
Category | HUMAN OTC DRUG LABEL |
Packager | Family Dollar (FAMILY WELLNESS) |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- Active ingredient (in each softgel)
- Purpose
- Uses
-
Warnings
Do not use
- with any other product containing diphenhydramine, even one used on skin
- for children under 12 years of age
- with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids
Ask a doctor before use if you have
- a breathing problem such as asthma, emphysema, or chronic bronchitis
- glaucoma
- heart disease
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers or any other sleep-aid.
When using this product
- drowsiness will occur
- avoid alcoholic beverages and other drugs that cause drowsiness
- be careful when driving a motor vehicle or operating machinery
-
Directions
- take only one dose per day (24 hours) - see Overdose warning
- swallow whole; do not crush, chew, or dissolve
- adults & children 12 yrs & over
- one dose = TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENT IN ZZZQUIL®*
EZ Nite Sleep
Nighttime Sleep-Aid
Diphenhydramine HCl, 25 mg
Non Habit-Forming
See Warnings
SOFTGELS**
(**Liquid-filled capsules)
DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.,
10401 MONROE RD., MATTHEWS, NC 28105 USA
FAMILYDOLLAR.COM
PRODUCT OF CANADA
*This product is not manufactured or distributed by The Procter & Gamble Company. VICKS®, LIQUICAPS®, and ZZZQUIL® are registered trademarks of The Proctor & Gamble Company.
Failure to follow these warnings could result in serious consequences.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
- Product Label
-
INGREDIENTS AND APPEARANCE
EZ NITE SLEEP NIGHTTIME SLEEP AID
diphenhydramine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-225 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PURPLE Score no score Shape CAPSULE Size 15mm Flavor Imprint Code A41 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-225-12 1 in 1 CARTON 10/30/2013 12/30/2021 1 12 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 OTC MONOGRAPH FINAL part341 10/30/2013 12/30/2021 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)