Label: ALLERGY RELIEF CHILDRENS- diphenhydramine hydrochloride liquid
- NDC Code(s): 33992-0292-4
- Packager: ASSURED / DOLLAR TREE (Greenbrier International, 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.
Updated July 6, 2016
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- Active ingredient (in each 5 mL)
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 the child has
- a breathing problem such as chronic bronchitis
- a sodium-restricted diet
When using this product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
- do not take more than 6 doses in 24 hours
- take every 4 to 6 hours, or as directed by a doctor
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL = milliliter
- find the right dose on the chart below
age (yr) dose (mL) children 6 to 11 years 5 mL to 10 mL children 2 to 5 years do not use unless directed by a doctor children under 2 years do not use
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
COMPARE TO ACTIVE INGREDIENT IN CHILDREN'S BENADRYL ALLERGY*
Oral Solution Diphenhydramine HCl 12.5 mg
- Alcohol Free
Relieves: Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Nose or Throat
FOR AGES 6-11 YEARS
FL OZ (mL)
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Benadryl® Allergy
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Distributed by: GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
- Product Label
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF CHILDRENS
diphenhydramine hydrochloride liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0292 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) GLYCERIN (UNII: PDC6A3C0OX) POLOXAMER 407 (UNII: TUF2IVW3M2) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SUCROSE (UNII: C151H8M554) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-0292-4 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 06/30/2016 Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)