Label: CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride solution
- NDC Code(s): 70000-0245-2
- Packager: CARDINAL HEALTH
- 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 October 4, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- Purpose
- Uses
-
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 the child has
- •
- a breathing problem such as chronic bronchitis
- •
- glaucoma
-
Directions
- •
- find right dose on chart below
- •
- take every 4 to 6 hours, or as directed by a doctor
- •
- do not take more than 6 doses in 24 hours
- •
- ml = milliliter
Age (yr)
Dose (mL)
children under 2 years
do not use
children 2 to 5 years
do not use unless directed by a doctor
children 6 to 11 years
5mL to 10 mL
Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- Other information
- Inactive ingredients
-
PRINCIPAL DISPLAY PANEL
LEADER™
NDC 70000-0245-2
Children’s Allergy Relief
Diphenhydramine HCl ǀ Antihistamine
12.5 mg/5 mL Oral solutionCOMPARE TO CHILDREN'S
BENADRYL® active ingredient*Cherry Flavor
For Relief of:
- Runny Nose,
- Itchy Throat or Nose,
- Sneezing,
- and
- Itchy, Watery Eyes
8 FL OZ (236 mL)
DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING*This product is not manufactured or distributed by Johnson and Johnson, owner of the registered trademark Children’s Benadryl®.
IMPORTANT: Keep this carton for future reference on full labeling.
- ©2017 Cardinal Health, All Rights Reserved, CARDINAL HEALTH, the Cardinal Health LOGO,LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners
- CARDINAL HEALTH™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
1-800-200-6313
Essential to Care™ since 1979
All Leader Brand Products have a 100% Money Back Guarantee
Return to place of purchase if not satisfied
-
INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY RELIEF
diphenhydramine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0245 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) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) FD&C RED NO. 40 (UNII: WZB9127XOA) glycerin (UNII: PDC6A3C0OX) POTASSIUM CITRATE (UNII: EE90ONI6FF) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) 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:70000-0245-2 1 in 1 CARTON 05/04/2017 1 236 mL in 1 BOTTLE, PLASTIC; 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 05/04/2017 Labeler - CARDINAL HEALTH (063997360)
