Label: GOOD NEIGHBOR PHARMACY SLEEP TIME- diphenhydramine hcl solution
- NDC Code(s): 46122-204-30
- Packager: Amerisource Bergen
- 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 October 31, 2017
If you are a consumer or patient please visit this version.
- Active ingredient (in each 30 mL)
Diphenhydramine HCl 50 mgClose
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to an enlargement of the prostate gland
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.
- Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).Close
- take only one dose per day (24 hours)
- only use the dose cup provided
adults & children 12 yrs & over
30 mL at bed time if needed or as directed by a doctor
children under 12 yrs
do not use
- Inactive Ingredients
alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrateClose
- Questions or comments?
- Package/Label Principal Display Panel
Compare to Vicks® ZzzQuil® active ingredient
50 mg per 30 mL
Not for treating Cold or Flu
6 fl oz (177 mL)Close
- INGREDIENTS AND APPEARANCE
GOOD NEIGHBOR PHARMACY SLEEP TIME
diphenhydramine hcl solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-204 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 ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLOXAMER 407 (UNII: TUF2IVW3M2) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color PURPLE Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-204-30 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/22/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 07/22/2013 Labeler - Amerisource Bergen (007914906)