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NDC Code(s): 67091-219-18 - Packager: WinCo Foods, LLC
- 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 December 9, 2019
If you are a consumer or patient please visit this version.
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- Active ingredient (in each 5 mL tsp)
Diphenhydramine HCl 12.5 mg
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
- 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
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
When using this product
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- marked drowsiness may occur
- excitability may occur especially in children
- 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 right away.
- Directions
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours
Age (yr) Dose (mL or tsp) children under 2 years do not use children under 6 years ask a doctor children 6 to under 12 years 1 to 2 tsp (5 mL to 10 mL) adults and children 12 years and above 2 to 4 tsp (10 mL to 20 mL) - Other information
- each tsp contains: sodium 5 mg
- dosing cup provided
- store at 68o - 77oF
- Inactive ingredients
carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol
- Questions?
1-800-824-1706 Monday -Friday 9am - 4pm MST.
You may also report side effects to this phone number
- PDP
*Compare to the active ingredient in Children's BENADRYL Dye Free Allergy Liquid
See AlsoSurvival for prostate cancerWinCo Foods
Children's Allery Relief
Diphenhydramine HCl 12.5 mg/Antihistamine
Relieves: Sneezing, Runny Nose, Itchy, Watery Eyes & Itchy Throat
Dye Free
Cherry Flavor
4 fl oz (118 mL)
- INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY RELIEF DYE FREE CHERRY
diphenhydramine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-219 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in5mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color white Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67091-219-18 1 in 1 CARTON 12/12/2014 1 118 mL in 1 BOTTLE; 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 12/12/2014 Labeler -WinCo Foods, LLC(056098817)
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More Info on this Drug
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CHILDRENS ALLERGY RELIEF DYE FREE CHERRY- diphenhydramine hcl liquid
Number of versions: 2
Published Date (What is this?) | Version | Files |
---|---|---|
Dec 10, 2019 | 2 (current) | download |
Dec 12, 2014 | 1 | download |
RxNorm
CHILDRENS ALLERGY RELIEF DYE FREE CHERRY- diphenhydramine hcl liquid
RxCUI | RxNorm NAME | RxTTY | |
---|---|---|---|
1 | 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN |
2 | 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD |
3 | 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY |
4 | 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY |
5 | 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY |
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CHILDRENS ALLERGY RELIEF DYE FREE CHERRY- diphenhydramine hcl liquid
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NDC Codes
CHILDRENS ALLERGY RELIEF DYE FREE CHERRY- diphenhydramine hcl liquid
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
NDC | |
---|---|
1 | 67091-219-18 (inactivated) |