Label: NIGHTTIME SLEEP AID BERRY FLAVOR- diphenhydramine hydrochloride liquid
- NDC Code(s): 67091-630-06
- Packager: WINCO FOODS, LLC
- 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.
Drug Label Information
Updated April 15, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 30 mL dose cup)
- Purpose
- Uses
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Warnings
Do not use
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- for children under 12 years of age
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- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
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- a breathing problem such as emphysema, or chronic bronchitis
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- glaucoma
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- difficulty in urination due to enlargement of the prostate gland
- Directions
- Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL
NDC 67091-630-06
Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid*
Nighttime Sleep-Aid
Diphenhydramine HCl
Non-Habit Forming
Makes you fall asleep fast
BERRY FLAVOR
Naturally and Artificially Flavored
No added alcohol
Not for Pain. Not for Colds.
Just for Sleep
6 FL OZ (177 mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN
*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.
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INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP AID BERRY FLAVOR
diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-630 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM CITRATE (UNII: EE90ONI6FF) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color PURPLE Score Shape Size Flavor BERRY (Naturally and Artificially) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67091-630-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/09/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/09/2023 Labeler - WINCO FOODS, LLC (056098817)