Label: TOPCARE ZZZ SLEEP- diphenhydramine hydrochloride solution
- NDC Code(s): 36800-200-30, 36800-200-34, 36800-200-40, 36800-200-50
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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
When using this product
- avoid alcoholic beverages
- drowsiness will occur
- do not drive a motor vehicle or operate 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.
- 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
- 30 mL at bed time if needed or as directed by a doctor
- children under 12 yrs
- do not use
- each 30 mL dose cup contains: sodium 20 mg
- store at 20-25°C (68-77°F)
- 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
50 mg PER 30 mL
COMPARE TO VICKS® ZzzQuil® active ingredient
Not for treating Cold or Flu
6 FL OZ (177 mL)Close
- INGREDIENTS AND APPEARANCE
TOPCARE ZZZ SLEEP
diphenhydramine hcl solution
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:36800-200 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 HIGH FRUCTOSE CORN SYRUP POLOXAMER 407 PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE Product Characteristics Color PURPLE (clear) Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-200-30 177 mL in 1 BOTTLE 2 NDC:36800-200-40 355 mL in 1 BOTTLE 3 NDC:36800-200-34 236 mL in 1 BOTTLE 4 NDC:36800-200-50 2 in 1 PACKAGE 4 355 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 08/20/2013 Labeler - Topco Associates LLC (006935977) Registrant - L. Perrigo Company (006013346) Establishment Name Address ID/FEI Business Operations L. Perrigo Company 006013346 MANUFACTURE(36800-200)