FDA Label for Childrens Chewable Allergy Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Childrens Chewable Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Kroger Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Chewable Tablet)
Diphenhydramine HCl 12.5 mg
Purpose
Antihistamine
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
-runny nose
-sneezing
-itchy, watery eyes
-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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When Using This Product
- marked drowsiness may occur
- avoid alcohol drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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 times in 24 hours
| Age (years) | 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 | 1 to 2 chewable tablets (12.5 mg to 25 mg) |
| adults and children 12 years and over | 2 to 4 chewable tablets (25 mg to 50 mg) |
Other Information
- store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
Inactive Ingredients
acacia, crospovidone, D&C red no. 30 aluminum lake, D&C red no. 7, dextrose monohydrate, ethylcellulose, FD&C blue no. 1 aluminum lake, flavors, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, sucralose, sucrose, tartaric acid
Questions Or Comments?
Call 1-800-632-6900
* Please review the disclaimer below.
