Label: SLEEP TIME- diphenhydramine hcl liquid
- NDC Code(s): 42507-186-30, 42507-186-40
- Packager: HyVee 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 September 16, 2013
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- Active ingredient (in each 30 mL dose cup)
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
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
- with other Nighttime products
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.
Overdose warning: Taking more than directed can cause serious health problems. 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) – see Overdose warning
- use dose cup
- adults & children 12 yrs & over
- One dose = 30 mL at bed time if needed or as directed by a doctor
- each 30 mL dose cup contains: sodium 20 mg
- store at 20-25 oC (68-77 oF)
- protect from light. Does not meet USP <671>.
- 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® Nighttime Sleep-Aid active ingredient
Night Time Sleep-Aid
50 mg per 30 mL
Nor for treating Cold or Flu
12 FL OZ (355 mL)Close
- INGREDIENTS AND APPEARANCE
diphenhydramine hcl liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-186 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:42507-186-30 177 mL in 1 BOTTLE 2 NDC:42507-186-40 355 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 07/08/2013 Labeler - HyVee Inc (006925671)