Label: CORRECT DOSE- diphenhydramine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 76103-004-10 - Packager: BFS Pharma, Inc.
- 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 May 25, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a sodium-restricted diet
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Directions
- refer to chart below
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours
Children under 2 years of age do not use Children 2 to 5 years of age do not use unless directed by a doctor Children 6 to 11 years of age 1 to 2 pre-filled spoons (12.5 mg to 25 mg) Adults and children 12 years of age and over 2 to 4 pre-filled spoons (25 mg to 50 mg) - Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CORRECT DOSE CHILDRENS ALLERGY RELIEF
diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76103-004 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 anhydrous citric acid (UNII: XF417D3PSL) D&C red NO. 33 (UNII: 9DBA0SBB0L) FD&C red NO. 40 (UNII: WZB9127XOA) glycerin (UNII: PDC6A3C0OX) glycyrrhizin, ammoniated (UNII: 3VRD35U26C) poloxamer 407 (UNII: TUF2IVW3M2) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sodium chloride (UNII: 451W47IQ8X) sodium citrate (UNII: 1Q73Q2JULR) sucrose (UNII: C151H8M554) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76103-004-10 10 in 1 CARTON 1 5 mL in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 06/15/2011 Labeler - BFS Pharma, Inc. (967271458)