Label: ADWE DYE-FREE CHILDRENS ALLERGY- diphenhydramine hydrochloride syrup
- NDC Code(s): 68163-710-08
- Packager: RARITAN PHARMACEUTICALS 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 August 16, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL)
- Purpose
- Uses
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Warnings
Do not use
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- to make a child sleepy
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- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if the child has
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- a breathing problem such as chronic bronchitis
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- glaucoma
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Directions
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- find right dose on chart below
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- take every 4 to 6 hours, or as directed by a doctor
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- do not take more than 6 doses in 24 hours
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- 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
5 mL 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
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PRINCIPAL DISPLAY PANEL
NDC 68163-710-08
Compare to active ingredient in Children'sBenadryl® Dye-Free*
Children’s Allergy Relief
Antihistamine
Diphenhydramine HCl
For Relief Of:
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- Runny nose
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- sneezing
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- itchy, watery eyes
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- Itchy Throat or Nose
- Natural Cherry Flavor
8 fl oz (236 mL)
Manufactured for:
Adwe Laboratories
1274th 49 Street
Brooklyn, NY 11219
*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Children’s Benadryl® Dye –Free.
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INGREDIENTS AND APPEARANCE
ADWE DYE-FREE CHILDRENS ALLERGY
diphenhydramine hydrochloride syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-710 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) glycerin (UNII: PDC6A3C0OX) POTASSIUM CITRATE (UNII: EE90ONI6FF) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color WHITE (Clear, colorless) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68163-710-08 1 in 1 CARTON 11/22/2021 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 11/22/2021 Labeler - RARITAN PHARMACEUTICALS INC (127602287)