Label: CURELIEF- diphenhydramine hcl solution
- NDC Code(s): 83335-103-04, 83335-103-16
- Packager: Wittman Pharma, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 18, 2024
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DOSAGE & ADMINISTRATION
Directions: Take every 4-6 hours, or as directed by doctor. * Do NOT exceed the recommended dose
Age Dose Adults and Children 12 years of age and over take 10 to 20 mL (2 to 4 tsp), not to exceed 300 mg in 24 hours Children 6 to under 12 years of age take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours Children under 6 years of age Consult a doctor -
WARNINGS
Warnings:
Do not use: ■ with any other product containing
diphenhydramine, even one used on skin ■ to make a
child sleepy
Ask a doctor before use if you have: ■ a breathing
problem such as emphysema or chronic bronchitis
■ glaucoma ■ trouble urinating due to the enlarged
prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product: ■ excitability might occur,
especially in children ■ marked drowsiness may occur
■ avoid alcoholic drinks ■ alcohol, sedatives, and
tranquilizers may increase drowsiness effect ■ be careful
when driving a motor vehicle or operating machinery
If pregnant or breast-feeding, ask a health
professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a
Poison Control Center (1-800-222-1222) right away.
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ACTIVE INGREDIENT
- Drug Facts
-
INGREDIENTS AND APPEARANCE
CURELIEF
diphenhydramine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83335-103 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) POTASSIUM CITRATE (UNII: EE90ONI6FF) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SUCRALOSE (UNII: 96K6UQ3ZD4) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITOL (UNII: 506T60A25R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83335-103-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2024 2 NDC:83335-103-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/01/2024 Labeler - Wittman Pharma, Inc. (830980947) Establishment Name Address ID/FEI Business Operations Wittman Pharma, Inc. 830980947 manufacture(83335-103) , analysis(83335-103) , label(83335-103)
