Label: NIGHTTIME SLEEP AID- diphenhydramine hcl liquid
- NDC Code(s): 41520-034-06, 41520-034-12
- Packager: Care One (American Sales Company)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 4, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each 30 mL)
- Purpose
- Uses
-
Warnings
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, nighttime cold/flu products, and other nighttime sleep-aids
Ask a doctor before use if you have
- heart disease
- glaucoma
- 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
-
Directions
- take only one dose per day (24 hours) - (see overdose warning)
- mL=milliliter
- 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=30 mL 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 the Active Ingredient in ZZZQUIL®*
NIGHTTIME SLEEP AID
Diphenhydramine HCI 50 mg
Alcohol 10%
Non-Habit-Forming
Not for treating cold or flu
Berry Flavor
FL OZ (mL)
Failure to follow these warnings could result in serious consequences
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.
DISTRIBUTED BY
FOODHOLD USA LLC
LANDOVER, MD 20785
1-877-846-9949
- Package Label
-
INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP AID
diphenhydramine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-034 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) ALCOHOL (UNII: 3K9958V90M) 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:41520-034-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2015 2 NDC:41520-034-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/30/2015 Labeler - Care One (American Sales Company) (809183973)
