tiny wellness 44-747

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (12.5 mg)

Inactive Ingredients

dextrose monohydrate ethylcellulose, unspecified hydroxypropyl cellulose, unspecified magnesium stearate mannitol stearic acid sucralose

Identifiers & Packaging

Pill Appearance

Imprint: 44;747 Shape: round Color: white Size: 12 mm Score: 1

Marketing Status

otc monograph drug active Since 2019-10-25

Medication Information

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

Purpose

Antihistamine

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

Description

Diphenhydramine HCl 12.5 mg

Principal Display Panel

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

Do Not Use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Questions Or Comments?

1-(888) 860-6888

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.

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

Active Ingredient (in Each Chewable Tablet)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

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

Purpose

Antihistamine

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 (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 (Inactive ingredients)

dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose

Principal Display Panel (Principal display panel)

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

Do Not Use (Do not use)

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Questions Or Comments? (Questions or comments?)

1-(888) 860-6888

When Using This Product (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, (If pregnant or breast-feeding,)

ask a health professional before use.

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 (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (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

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Diphenhydramine HCl 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DEXTROSE MONOHYDRATE", "unii": "LX22YL083G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLCELLULOSE, UNSPECIFIED", "unii": "7Z8S9VYZ4B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE, UNSPECIFIED", "unii": "9XZ8H6N6OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Antihistamine", "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)", "Do not use": "to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "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", "Principal display panel": "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", "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.", "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", "Active ingredient (in each chewable tablet)": "Diphenhydramine HCl 12.5 mg", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information