Active Ingredient (In Each Chewable Tablet)
Diphenhydramine HCl 12.5 mg
Allergies Tablet, Chewable
FDA Label NDC 73418-747
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unconditional Love for the product Allergies (NDC 73418-747). 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
- 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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
- avoid alcoholic beverages
- 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
dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose
Questions Or Comments?
1-(888) 860-6888
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TINY
WELLNESS CO
6 YEARS &
OLDER
Natural
Flavor
Dye Free
MY CHILD NEEDS HELP WITH:
Allergies
DIPHENHYDRAMINE HCl, 12.5 mg
Chewable Tablets / Antihistamine
4-6 Hour Dose
Relief for runny nose, sneezing, itchy
watery eyes, itchy throat or nose.
Chew or crush tablets completely before swallowing.
20
chewable
tablets
NATURAL
GRAPE FLAVOR
TAMPER EVIDENT:
DO NOT USE IF
PACKAGE IS OPENED OR
IF BLISTER UNIT IS TORN,
BROKEN OR SHOWS
ANY SIGNS OF
TAMPERING
Distributed by:
Tiny Wellness Co.
Los Angeles, CA
90272
Questions? Call and ask
at (888) 860-6888
50844 ORG091974709
Tiny Wellness 44-747 (Tiny Wellness 44 747 1)
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