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Dextromethorphan Polistirex Extended-Release

제형
SUSPENSION
업체
Amneal Pharmaceuticals LLC
원문 갱신
2024-06-27
가져온 날
2026-09-07
유효 성분
DEXTROMETHORPHAN HYDROBROMIDE
DailyMed 원문·등록 이미지 확인 ↗
기타 원문Label information

Drug Facts

유효 성분OTC - ACTIVE INGREDIENT

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

성분·작용OTC - PURPOSE

Purpose

Cough suppressant

효능·용도INDICATIONS AND USAGE

Uses

Temporarily relieves

  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the impulse to cough to help you get to sleep
주의사항WARNINGS

Warnings

OTC - DO NOT USEOTC - DO NOT USE

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

OTC - ASK DOCTOROTC - ASK DOCTOR

Ask a doctor before use if you have

  • chronic cough that lasts such as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDINGOTC - PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDRENOTC - 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 right away.

복용법·사용법DOSAGE AND ADMINISTRATION

Directions

  • shake bottle well before use
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
 adults and children 12 years of age and over  10 mL every 12 hours,
not to exceed 20 mL in 24 hours
 children 6 to under 12 years of age  5 mL every 12 hours,
not to exceed 10 mL in 24 hours
 children 4 to under 6 years of age  2.5 mL every 12 hours,
not to exceed 5 mL in 24 hours
 children under 4 years of age  do not use

Other information

  • each 5 mL contains: sodium 7 mg
  • store at 20° to 25°C (68° to 77°F)
  • dosing cup provided
첨가제INACTIVE INGREDIENT

Inactive ingredients

citric acid, corn oil, edetate disodium, ethylcellulose, FD&C Yellow No. 6, flavor, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sodium polystyrene sulfonate, sucrose, tragacanth, xanthan gum.

Hydrochloric acid or sodium hydroxide solution, if required, to adjust the pH.

제조사 문의OTC - QUESTIONS

Questions?

Call 1-877-835-5472, Mon through Fri 9AM to 5PM EST.

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 06-2024-01

포장 표시PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[Image in the official label — see DailyMed source]

Label information

[Image in the official label — see DailyMed source]

DailyMed Set ID: ce7402d1-e48f-4bf1-90e9-cc57a52b35e5 · 버전 13
NDC: 65162-700