ALLERGIES MY CHILD NEEDS HELP WITH- diphenhydramine hcl tablet, chewable

Allergies by

Drug Labeling and Warnings

Allergies by is a Otc medication manufactured, distributed, or labeled by Unconditional Love, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
    

Warnings

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

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

INGREDIENTS AND APPEARANCE

ALLERGIES  MY CHILD NEEDS HELP WITH
diphenhydramine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73418-747
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	12mm
Flavor	GRAPE (natural)	Imprint Code	44;747
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73418-747-09	4 in 1 CARTON	10/25/2019
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/25/2019

Labeler - Unconditional Love (081135707)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	MANUFACTURE(73418-747) , PACK(73418-747)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(73418-747)