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NDC 71594-0705-08 FIRSTCARE CHILDRENS ALLERGY RELIEF 12.5 mg/1 Details

FIRSTCARE CHILDRENS ALLERGY RELIEF 12.5 mg/1

FIRSTCARE CHILDRENS ALLERGY RELIEF is a ORAL BAR, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by USpharma Ltd. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 71594-0705-08
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	71594-0705
Product ID	71594-705_b6996dd1-a495-2df8-e053-2995a90acfb3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	FIRSTCARE CHILDRENS ALLERGY RELIEF
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	BAR, CHEWABLE
Route	ORAL
Active Ingredient Strength	12.5
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	USpharma Ltd
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71594-0705-08 (71594070508)

Pricing Information	N/A
NDC Package Code	71594-705-08
Billing NDC	71594070508
Package	20 BAR, CHEWABLE in 1 BOTTLE (71594-705-08)
Marketing Start Date	2020-05-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 540c38ec-3787-4a27-8c5e-5401e3960e20 Details

Active ingredient (in each soft chew)

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 soft chew thoroughly before swallowing

find right dose on chart below

Age (yr)	Dose (soft chew)
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 soft chews (12.5 mg to 25 mg)
Adults and children 12 years and over	2 to 4 soft chews (25 mg to 50 mg)

SPL UNCLASSIFIED SECTION

Other information

each soft chew contains sodium 7 mg.

very low sodium

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:

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

SPL UNCLASSIFIED SECTION

Questions or comments?

Call 1-800-227-6151

Package/Label Principal Display Panel

FIRSTCARE TM

***MADE IN USA***

Bubble Gum Flavored

CHILDEREN'S ALLERGY RELIEF

Diphenhydramine HCl Anthihistamine 12.5 mg

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

CHEWY BITES

20 SOFT CHEWS

NDC 71594-705-08

Patent Pending

INGREDIENTS AND APPEARANCE

FIRSTCARE CHILDRENS ALLERGY RELIEF

diphenhydramine hcl bar, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71594-705
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	yellow (Light yellow to golden brown)	Score	no score
Shape	RECTANGLE	Size	18mm
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71594-705-08	20 in 1 BOTTLE; Type 0: Not a Combination Product	05/21/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	05/21/2020

Labeler - USpharma Ltd (080664601)

Registrant - USpharma Ltd (080664601)

Name	Address	ID/FEI	Business Operations
Establishment
USpharma Ltd		080664601	manufacture(71594-705) , pack(71594-705)

Revised: 12/2020

Document Id: b6996dd1-a495-2df8-e053-2995a90acfb3

Set id: 540c38ec-3787-4a27-8c5e-5401e3960e20

Version: 2

Effective Time: 20201216

Search by Drug Name or NDC

NDC 71594-0705-08 FIRSTCARE CHILDRENS ALLERGY RELIEF 12.5 mg/1 Details

FIRSTCARE CHILDRENS ALLERGY RELIEF 12.5 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71594-0705-08 (71594070508)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 540c38ec-3787-4a27-8c5e-5401e3960e20 Details

Active ingredient (in each soft chew)

Purpose

Uses

Warnings

Ask a doctor before use if you have

When using this product

Directions

SPL UNCLASSIFIED SECTION

Inactive ingredients:

SPL UNCLASSIFIED SECTION

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

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