FDA Label for Childrens 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
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
Childrens Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Target Corporation. 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
- 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
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the 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 beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution 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 (1-800-222-1222) right away.
Directions
- find right dose on chart below
- chew or crush tablets completely before swallowing; 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 (yr) | 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
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive Ingredients
D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose
Questions?
Call 1-800-910-6874
Principal Display Panel
NDC 11673-985-09
Compare to active ingredient in
Children’s Benadryl® Chewables*
children’s
allergy relief
diphenhydramine HCl, 12.5 mg chewable tablets
antihistamine
relieves:
• sneezing
• itchy, watery eyes
• runny nose
• itchy throat or nose
chew or crush tablets completely
before swallowing.
up&up™
20 CHEWABLE TABLETS
GRAPE FLAVOR
ACTUAL SIZE
CHEWABLE TABLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
Dist. by Target Corporation
Minneapolis, MN 55403
TM & ©2019 Target Brands, Inc.
*This product is not manufactured or
distributed by Johnson & Johnson
Corporation, owner of the registered
trademark Children’s Benadryl®
Chewables.
50844 ORG121858509
* Please review the disclaimer below.