Active Ingredient (In Each Chewable Tablet)
Diphenhydramine HCl 12.5 mg
Topcare Tablet, Chewable
FDA Label NDC 76162-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Topcare (NDC 76162-201). 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 chewable tablet), purpose, uses, do not use, ask a 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 A Doctor Before Use If You Have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- 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
- find right dose on chart below
- Chew one tablet completely at the onset of symptoms. Do not swallow tablets whole.
- take every 4 to 6 hours or as directed by a doctor
- do not take more than 6 times in 24 hours
Age (Year) | Dose (Chewable tablets) |
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 of age | 1 to 2 chewable tablets (12.5 mg to 25 mg) |
adults and children 12 years of age and over
| 2 to 4 tablets (25 mg to 50 mg) |
Other Information
- each chewable tablet contains: sodium 3 mg
- store 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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Compare to the active ingredient in Children's Benadryl® Allergy Chewable Tablets*
NDC 76162-201-20
Children’s Allergy Chews
Diphenhydramine HCl, / Antihistamine
For Relief of:
- sneezing
- runny nose
- itchy throat or nose
- itchy, watery eyes
4-6 Hours/Dose
Grape Flavor
Naturally and Artificially Flavored
20 Chewable Tablets
TAMPER EVIDENT: DO NOT USE IF CARTON OR IF BLISTER UNIT IS BROKEN OR OPEN.
*This product is not manufactured or distributed by Kenvue INC., owner of the registered trademark Children's Benadryl® Allergy Chewable Tablets*.
Distributed by:
Topco Childrens Allergy Chews 20 Counts (Childrens Allergy Melts Cherry 1)
* Please review the disclaimer below.
