FIRSTCARE CHILDRENS ALLERGY DIPHENHYDRAMINE HCL CHEWABLE GELS- diphenhydramine chewable gel

FirstCare Childrens Allergy Diphenhydramine HCl Chewable Gels by

Drug Labeling and Warnings

FirstCare Childrens Allergy Diphenhydramine HCl Chewable Gels by is a Otc medication manufactured, distributed, or labeled by USpharma Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each chewable gel)

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 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
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

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

• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 times in 24 hours
• Instruct child to chew each chewable gel thoroughly before swallowing
• find right dose on chart below
  • Age (yr):

    Dose (chewable gels)

  • 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 gels (12.5 mg to 25 mg)

  • Adults and children 12 years and over:

    2 to 4 chewable gels (25 mg to 50 mg)

SPL UNCLASSIFIED SECTION

Other information

• each chewable gel: contains sodium 7 mg.
• store in a cool dry place between 20-25°C (68-77°F).

Child Resistant Container;do not use if printed seal under cap is broken or missing.

Inactive ingredients:

trisodium citrate dihydrate, sodium chloride, sucralose, neotame, glucose syrup, seaweed extract (carrageenan), maltitol solution, hydroxypropyl betadex, maltodextrin, flavor, sucrose, mineral oil, starch, citric acid, purified water.

SPL UNCLASSIFIED SECTION

Questions or comments?

Call 1-800-227-6151

Package/Label Principal Display Panel

FIRST CARETM

***MADE IN USA***

CHILDEREN'S ALLERGY RELIEF

Diphenhydramine HCl Anthihistamine 12.5 mg Chewable Gels

• Runny Nose & Sneezing
• Itchy throat or Nose
• Itchy, Water Eyes

14 Bubble Gum Flavored Gummies NDC: 71594-700-04

INGREDIENTS AND APPEARANCE

FIRSTCARE CHILDRENS ALLERGY DIPHENHYDRAMINE HCL CHEWABLE GELS 
diphenhydramine chewable gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71594-700
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
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SUCRALOSE (UNII: 96K6UQ3ZD4)
NEOTAME (UNII: VJ597D52EX)
CORN SYRUP (UNII: 9G5L16BK6N)
CARRAGEENAN (UNII: 5C69YCD2YJ)
MALTITOL (UNII: D65DG142WK)
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCROSE (UNII: C151H8M554)
MINERAL OIL (UNII: T5L8T28FGP)
STARCH, CORN (UNII: O8232NY3SJ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	yellow (Light yellow to golden brown)	Score
Shape	RECTANGLE	Size	18mm
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71594-700-04	14 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/01/2020

Labeler - USpharma Ltd (080664601)

Registrant - USpharma Ltd (080664601)

Establishment
Name	Address	ID/FEI	Business Operations
USpharma Ltd		080664601	manufacture(71594-700) , pack(71594-700)