Active Ingredient (In Each Tablet)
Diphenhydramine HCl 12.5 mg
Drx Choice Childrens Allergy Chews Tablet, Chewable
FDA Label NDC 68163-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals Inc for the product Drx Choice Childrens Allergy Chews (NDC 68163-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask your doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
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
Do Not Use
▪ to make a child sleepy▪ with any other product containing diphenhydramine, even one used on skin
Ask Your Doctor Before Use If You Have
▪ glaucoma▪ a breathing problem such as emphysema or chronic bronchitis▪ trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
▪ marked drowsiness may occur▪ avoid alcoholic drinks▪ alcohol, sedatives, and tranquilizers may increase drowsiness▪ be careful when driving a motor vehicle or operating machinery▪ excitability may occur, especially in children
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 at 1-800-222-1222
Directions
▪ chew one tablet completely at the onset of symptoms. Do not swallow tablets whole.▪ 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
Age (Yr) | Dose (chewable tablets) |
children under 2 years of age | do not use |
children 2 to under 5 years of age | do not use unless directed by a doctor |
children 6 to under 12 years of age | 1 to 2 tablets |
adults and children 12 years of age and over | 2 to 4 tablets |
Other Information
▪ store below at room temperature. Avoid high humidity. Protect from light.
Inactive Ingredients
citric acid, crospovidone, D&C Red No.30, dextrose, FD&C Blue No 1, flavors, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose
Questions Or Comments ?
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NDC 68163-012-48
Compare to active ingredient in Children's Benadryl® Allergy Chewable Tablets
DRx Choice
children's allergy chews
diphenhydramine HCl, 12.5 mg/ antihistamine
For Relief of:
- Sneezing
- Runny nose
- Itchy throat or Nose
- Itchy, watery eyes
48 Chewable Tablets
Grape Flavor
4-6 HOURS/DOSE
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Johnson & Johnson Consumer INC, owner of the registered trademark Children's Benadryl® Allergy Chewable Tablets.
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court,
East Brunswick,
NJ 08816
IMPORTANT: Keep this carton for future reference on full labelling
Drx Choice Children's Allergy Chews 48 Tablets (Childrens Allergy Melts Cherry 1)
* Please review the disclaimer below.
