Label: NIGHTTIME SLEEP AID- diphenhydramine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55315-003-12 - Packager: fred's, Inc.
- Category: HUMAN OTC DRUG LABEL
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 December 30, 2013
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 30 mL or 2 tablespoons)
- Purpose
- Uses
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Warnings
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
Ask a doctor before use if you have
- a breathing problem such as asthma, emphysema, or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- heart disease
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid
When using this product
- avoid alcoholic beverages and other drugs that cause drowsiness
- drowsiness will occur
- be careful when driving a motor vehicle or operating machinery
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Directions
- take only one dose per day (24 hours) – see Overdose warning
- use dose cup or tablespoon
adults & children 12 yrs & over One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor - Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
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INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP AID
diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-003 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 Sodium Benzoate (UNII: OJ245FE5EU) Citric Acid Monohydrate (UNII: 2968PHW8QP) Sorbitol (UNII: 506T60A25R) Saccharin Sodium (UNII: SB8ZUX40TY) Alcohol (UNII: 3K9958V90M) FD&C RED NO. 40 (UNII: WZB9127XOA) Sodium Citrate (UNII: 1Q73Q2JULR) Glycerin (UNII: PDC6A3C0OX) FD&C Blue NO. 1 (UNII: H3R47K3TBD) Water (UNII: 059QF0KO0R) Product Characteristics Color PURPLE (Dark) Score Shape Size Flavor CHERRY, BERRY, STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55315-003-12 177 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part338 10/23/2013 Labeler - fred's, Inc. (005866116) Registrant - davAgen Pharmaceutical, LLC (967545935) Establishment Name Address ID/FEI Business Operations davAgen Pharmaceutical, LLC 967545935 MANUFACTURE(55315-003) , PACK(55315-003) , LABEL(55315-003) , ANALYSIS(55315-003)