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Diphenhydramine HCl Oral Solution

제형
SOLUTION
업체
Natco Pharma USA LLC
원문 갱신
2023-11-01
가져온 날
2026-09-07
유효 성분
DIPHENHYDRAMINE HYDROCHLORIDE
DailyMed 원문·등록 이미지 확인 ↗
기타 원문Label information

Drug Facts

유효 성분Active ingredient (in each 5 mL)

Diphenhydramine HCl USP 12.5 mg

유효 성분Active ingredient (in each 10 mL)

Diphenhydramine HCl USP 25 mg

성분·작용Purpose

Antihistamine

효능·용도Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat

주의사항Warnings

Do not use

• in neonates or premature infants • if pregnant or breast-feeding • if hypersensitive to diphenhydramine HCI and other similar antihistamine • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy

Ask a doctor before use if you have

• glaucoma • a breathing problem such as emphysema or chronic bronchitis
• a sodium restricted diet • trouble urinating due to enlarged prostate gland

Label information

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

When using this product

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

Label information

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

복용법·사용법Directions

• Use the following dosage guidelines when using this product

Age (yr) Dose (mL)
Adults and children 12
years and older
take 10 mL every 4 to 6 hours; not more than 60 mL
in 24 hours.
Children 6 years to under
12 years
take 5 mL every 4 to 6 hours; not more than 30 mL
in 24 hours
Children under 6 years ask a doctor
Other informationOther information

• each 5mL contains sodium 10mg
• each 10mL contains sodium 20mg
• alcohol free, cherry flavor
• store at 20-25°C (68-77°F)
• protect from excessive moisture
• do not use if lid seal is open or damaged
• see top of cup for lot number and expiration date

첨가제Inactive ingredients

Citric acid, D&C Red No. 33, FD&C Red No. 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate,
and sucrose.

How SuppliedHow Supplied

Each 5 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 12.5mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms:


NDC 69339-151-05             (1) unit dose cup                         5mL
NDC 69339-151-17             40 (4x10) unit dose cups            5mL
NDC 69339-151-19             100 (10x10) unit dose cups        5mL

Each 10 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 25mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms:

NDC 69339-152-01             (1) unit dose cup                         10mL
NDC 69339-152-17             40 (4x10) unit dose cups            10mL
NDC 69339-152-19             100 (10x10) unit dose cups        10mL

제조사 문의Questions or comments?

Call 201-786-6500

Dash Pharmaceuticals LLC
Upper Saddle River, NJ 07458

DP-UD-PI-AT-[117894] Rev 08/20

포장 표시PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 69339-151-05

Diphenydramine HCl Oral Solution, USP

12.5 mg/5 mL

For Institutional Use Only

3 69339 15105 1

Lot # 000000

Exp: MM/YYY

See Insert

DASH Pharmaceuticals LLC

Upper Saddle River, NJ 07458

DASH-

DOSE

[Image in the official label — see DailyMed source]

포장 표시PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC 69339-152-01

Diphenydramine HCl Oral Solution, USP

25 mg/10 mL

For Institutional Use Only

3 69339 15201 0

Lot # 000000

Exp: MM/YYY

See Insert

DASH Pharmaceuticals LLC

Upper Saddle River, NJ 07458

DASH-

DOSE

[Image in the official label — see DailyMed source]

DailyMed Set ID: 54b64354-ac10-42ff-a53d-96cef933a91a · 버전 6
NDC: 69339-151, 69339-152