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GUAIFENESIN DM

제형
SYRUP
업체
PAI Holdings, LLC dba PAI Pharma
원문 갱신
2024-11-11
가져온 날
2026-09-07
유효 성분
GUAIFENESIN
DailyMed 원문·등록 이미지 확인 ↗
성분·작용성분·작용

Non-Narcotic, Alcohol Free
Expectorant/Cough Suppressant

유효 성분DESCRIPTION
Each 5 mL (1 teaspoonful) contains:
Guaifenesin 100 mg
Dextromethorphan Hydrobromide 10 mg

첨가제

Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose. 

Sodium Content: 4 mg/5 mL

효능·용도USES
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
주의사항WARNINGS

Label information

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.

Ask a doctor before use if you have

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

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • you are hypersensitive to any of the ingredients.

Label information

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

Label information

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

기타 원문Label information

Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

복용법·사용법복용법·사용법

DIRECTIONS: Follow dosage below or use as directed by a physician.

  • do not take more than 6 doses in any 24-hour period.
age dose
adults and children
12 years and over
10 mL (2 teaspoonfuls)
every 4 hours
children 6 years to
under 12 years
5 mL (1 teaspoonful)
every 4 hours
children 2 years to
under 6 years
2.5 mL (1/2 teaspoonful)
every 4 hours
children under 2 years ask a doctor
기타 원문Label information

HOW SUPPLIED: Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms:

NDC 0121-0638-04:  4 fl oz (118 mL) bottle

NDC 0121-0638-08:  8 fl oz (237 mL) bottle

NDC 0121-0638-16:  16 fl oz (473 mL) bottle

NDC 0121­0638-05:  5 mL unit dose cup

NDC 0121-0638-00:  Case contains 100 unit dose cups of 5 mL (0121-0638-05) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-1276-10:  10 mL unit dose cup

NDC 0121-1276-00:  Case contains 100 unit dose cups of 10 mL (0121-1276-10) packaged in 10 trays of 10 unit dose cups each.

보관·기타 정보보관·기타 정보

STORAGE: Keep tightly closed.  Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP].  Protect from light. 

MANUFACTURED BYMANUFACTURED BY

Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com 

R11/16

포장 표시PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

Delivers 5 mL
NDC 0121-0638-05

GUAIFENESIN SYRUP
and DEXTROMETHORPHAN

100 mg/10 mg per 5 mL

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

[Image in the official label — see DailyMed source]

포장 표시PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 0121-0638-04
NSN 6505-01-318-1565

Quality ®
Value

Guaifenesin-DM

100 mg/10 mg per 5 mL

EXPECTORANT/COUGH SUPPRESSANT

Compare to the
active ingredients in
*Robitussin ®-DM

CONTROLS COUGHS

LOOSENS AND RELIEVES
CHEST CONGESTION

4 fl oz (118 mL)

Pharmaceutical
Associates, Inc.

Greenville, SC 29605

[Image in the official label — see DailyMed source]

포장 표시PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

NDC 0121-0638-08

Quality ®
Value

Guaifenesin-DM

100 mg/10 mg per 5 mL

EXPECTORANT/COUGH SUPPRESSANT

Compare to the
active ingredients in
*Robitussin ®-DM

CONTROLS COUGHS

LOOSENS AND RELIEVES
CHEST CONGESTION

8 fl oz (237 mL)

Pharmaceutical
Associates, Inc.

Greenville, SC 29605

[Image in the official label — see DailyMed source]

포장 표시PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 0121-0638-16

Quality ®
Value

Guaifenesin-DM

100 mg/10 mg per 5 mL

EXPECTORANT/COUGH SUPPRESSANT

Compare to the
active ingredients in
*Robitussin ®-DM

CONTROLS COUGHS

LOOSENS AND RELIEVES
CHEST CONGESTION

16 fl oz (473 mL)

Pharmaceutical
Associates, Inc.

Greenville, SC 29605

[Image in the official label — see DailyMed source]

포장 표시PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

Delivers 10 mL

NDC 0121-1276-10

GUAIFENESIN SYRUP

and DEXTROMETHORPHAN

200 mg/20 mg per 10 mL

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

[Image in the official label — see DailyMed source]

DailyMed Set ID: ff970fff-d1a3-4322-83b4-34e361431a1c · 버전 8
NDC: 0121-0638, 0121-1276