Label: EZ NITE SLEEP AID- diphenhydramine hcl liquid
- NDC Code(s): 49035-675-12
- Packager: EQUATE (Wal-Mart Stores, Inc.)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated December 11, 2019
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- Active ingredient (in each 30 mL)
Do not use
- with any other product containing diphenhydramine, even one used on the skin
- for children under 12 years of age
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products, and other nighttime sleep-aids
Ask a doctor before use if you have
- heart disease
- a breathing problem such as asthma, emphysema or chronic bronchitis
- 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 drinks and other drugs that cause drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
- take only one dose per day (24 hours) - (see overdose warning)
- shake well before using
- measure only with dosing cup provided
- do not use any other dosing device
- keep dosing cup with product
- adults and children 12 years and over
- one dose=30mL at bedtime if needed, or as directed by a doctor
- children under 12 years do not use
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
Compare to ZZZQUIL® Active Ingredient*
EZ Nite Sleep Aid
Diphemhydramine HCl 50 mg
- non habit forming
- berry flavor
Not for treating Cold or Flu
FL OZ (mL)
Failure to follow these warnings could result in serious consequences
Distributed by: Wal-Mart Stores, Inc.,
Bentonville, AR 72716
*This product is not manufactured or distributed by The Procter & Gamble Company.
ZZZQUIL® is a registered trademark of The Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
- Package Label
INGREDIENTS AND APPEARANCE
EZ NITE SLEEP AID
diphenhydramine hcl liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-675 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 30 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-675-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part338 10/31/2015 Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)