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Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl

제형
CAPSULE, LIQUID FILLED
업체
ONE2ZEE LIMITED LIABILITY COMPANY
원문 갱신
2021-02-28
가져온 날
2026-09-07
유효 성분
ACETAMINOPHEN · DEXTROMETHORPHAN HYDROBROMIDE · GUAIFENESIN
DailyMed 원문·등록 이미지 확인 ↗
유효 성분Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine Hydrochloride 5 mg

성분·작용Purpose

Pain reliever/ fever reducer

Cough suppressant

Expectorant

Nasal decongestant

효능·용도Uses
  • temporarily relieves common cold/flu symptoms:

      ο   nasal congestion
      ο   sinus congestion & pressure
      ο   cough due to minor throat & bronchial irritation
      ο   minor aches & pains
      ο   headache
      ο   fever
      ο   sore throat

  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
주의사항Warnings:

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 4 softgels in 24 hours, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

  • with any other drug containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product do not use more than directed

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

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

Keep out of reach of children.

Overdose warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

복용법·사용법Directions
  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hours

adults & children 12 years of age and over 2 softgels with water every 4 hours
Children under 12 years of age  ask a doctor

When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

첨가제Inactive ingredients

polyethylene glycol 400, propylene glycol, povidone k30, fd&c yellow no. 6, titanium dioxide, gelatin, glycerin, sorbitol, water

보관·기타 정보Other Information:
  • store at room temperature 59°-86°F (15°-30°C)
포장 표시PRINCIPAL DISPLAY PANEL - Shipping Label

Acetaminophen, Dextromethorphan HBr, Guifenesin, Phenylephrine HCL capsules

Each Softgel Contains:
(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg, Guifenesin 200mg, Phenylephrine Hydrochloride USP 5mg)

LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 55629-015-
EXP DATE:

WARNING:
KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.

CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C.ACT AND REGULATIONS THEREUNDER.

[Image in the official label — see DailyMed source]

DailyMed Set ID: de4d25ea-6f0e-49d8-b2ad-fdccf95f54ca · 버전 1
NDC: 55629-015