Label: DIPHENHYDRAMINE HYDROCHLORIDE liquid
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NDC Code(s):
81033-003-05,
81033-003-10,
81033-003-40,
81033-003-41, view more81033-003-50, 81033-003-52
- Packager: Kesin Pharma Corporation
- 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 January 16, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT (in each 5 mL)
- PURPOSE
- USES
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WARNINGS
Do not use
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin
• this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland
Ask a doctor before use if your child has
• a breathing problem such as chronic bronchitis
• glaucoma
• a sodium-restricted diet
When using this product
• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness
• excitability may occur, especially in children
• avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.
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DIRECTIONS
Adults and children 12 years of age and over: oral dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300 milligrams in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS or COMMENTS?
- HOW SUPPLIED
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PRINCIPAL DISPLAY PANEL
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NDC 81033-003-05
Diphenhydramine
HCl Oral Solution
Delivers 12.5mg / 5 mL
12.5mg / 5 mL
Store at 68° - 77° F
[ Lot # Exp Date]
PKG by Kesin Pharma
Phoenix, AZ
Sugar, Alcohol, Dye Free
For Institutional Use Only
[Barcode]
[Barcode]
NDC 81033-003-10
Diphenhydramine
HCl Oral Solution
Delivers 25mg / 10 mL
12.5mg / 5 mL
Store at 68° - 77° F
[Lot #] PKG by
[Exp Date] Kesin Pharma
Phoenix, AZ
Sugar, Alcohol, Dye Free
For Institutional Use Only
[Barcode]
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81033-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color Score Shape Size Flavor BERRY (Mixed Berry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81033-003-52 8 in 1 CASE 09/16/2021 1 NDC:81033-003-50 50 in 1 CARTON 1 NDC:81033-003-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:81033-003-41 8 in 1 CASE 09/16/2021 2 NDC:81033-003-40 40 in 1 CARTON 2 NDC:81033-003-10 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/16/2021 Labeler - Kesin Pharma Corporation (117447816)