FDA Label for Children Allergy Relief Bubblegum Flavor
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF THE CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
- WHEN USING THIS PRODUCT
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Children Allergy Relief Bubblegum Flavor 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 5 Ml)
Diphenhydramine HCl USP 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 The Child Has
▪ a breathing problem such as chronic bronchitis▪ glaucoma
Ask A Doctor Or Pharmacist Before Use If The Child Is
taking sedatives or tranquilizers.
When Using This Product
▪ marked drowsiness may occur▪ sedatives and tranquilizers may increase drowsiness▪ excitability may occur, especially in children
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▪ take every 4 to 6 hours, or as directed by a doctor▪ do not take more than 6 doses in 24 hours▪ mL = milliliter
Age (yr) | Dose (mL) |
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 | 5 mL to 10 mL |
Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
Other Information
• each 5 mL contains: sodium 15 mg• store at room temperature• see bottom panel for lot number and expiration date• protect from light• contains low sodium
Inactive Ingredients
anhydrous citric acid, carboxymethylcellulose sodium, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.
Questions Or Comments?
1-800-910-6874
Principal Display Panel
NDC 11673-832-04
Compare to active ingredient Children’s Benadryl® Dye-Free*
dye-free
children’s allergy relief
diphenhydramine HCl 12.5 mg,
Antihistamine/5 mL Oral Solution
Sugar free
for relief of:
• Runny Nose• Sneezing• Itchy, Watery Eyes• Itchy Throat or Nose
BUBBLEGUM FLAVOR
Naturally and Artificially Flavored
AGES 6+ YEARS
4 FL OZ (118 mL)
100% satisfaction guaranteed or your money back.
Each year we give 5% of our profit to communities, which add up to more than $4 Million a week. See all the good we do together at Target.com/Community.
*This product is not manufactured or distributed by Johnson & Johnson owner of the registered trademark Children’s Benadryl® Dye-Free.
094 04 0378 R01 ID205457
Distributed by Target Corporation
Minneapolis, MN 55403
® & © 2019 Target Brands, Inc.
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IMPORTANT: Keep this carton for future reference on full labeling. |
DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING
* Please review the disclaimer below.