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GUAIFENESIN DM by Pharmaceutical Associates, Inc.

Dosage form: syrup
Ingredients: GUAIFENESIN 100mg in 5mL, DEXTROMETHORPHAN 10mg in 5mL
Labeler: Pharmaceutical Associates, Inc.
NDC Code: 0121-0638

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

GUAIFENESIN DM

Non-Narcotic, Alcohol Free
Expectorant/Cough Suppressant

DESCRIPTION
Each 5 mL (1 teaspoonful) contains:
Guaifenesin100 mg
Dextromethorphan Hydrobromide10 mg

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

USES
  • 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

WARNINGS

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.

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 right away.

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).

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

  • do not take more than 6 doses in any 24-hour period.
agedose
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 yearsask a doctor

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.

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

MANUFACTURED BY

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

R11/16

PRINCIPAL 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

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

F06380500

PRINCIPAL 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

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

A06381001

PRINCIPAL 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

DRUG FACTS

Active Ingredient (in each 5 mL teaspoonful)       Purpose

Guaifenesin  100 mg...................................................Expectorant
Dextromethorphan Hydrobromide  10 mg......Cough Suppressant

Uses

  • 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

Warnings

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 accompanies by fever, rash or
persistent headache. 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. In case or overdose, get
medical help or contact a Poison Control Center right away.

Directions

  • do not take more than 6 doses in any 24-hour period 
agedose
adults and children
12 years and over
2 teaspoonfuls
every 4 hours
children 6 years to
under 12 years
1 teaspoonful
every 4 hours
children 2 years to
under 6 years
1/2 teaspoonful
every 4 hours
under 2 yearsask a doctor

Other Information

  • store at 20°-25°C (68°-77°F)
  • alcohol-free
  • packaged with tamper evident seal around cap
  • sodium content 4 mg/5 mL

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

*Robitussin® is a registered trademark of Wyeth Consumer Healthcare.

PRINCIPAL 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

DRUG FACTS

Active Ingredient (in each 5 mL teaspoonful)  Purpose

Guaifenesin  100 mg...................................................Expectorant
Dextromethorphan Hydrobromide  10 mg......Cough Suppressant

Uses

  • 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

Warnings

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 accompanies by fever, rash or
persistent headache. 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. In case or overdose, get
medical help or contact a Poison Control Center right away.

Directions

  • do not take more than 6 doses in any
    24-hour period
agedose
adults and children
12 years and over
2 teaspoonfuls
every 4 hours
children 6 years to
under 12 years
1 teaspoonful
every 4 hours
children 2 years to
under 6 years
1/2 teaspoonful
every 4 hours
under 2 yearsask a doctor

Other Information

  • store at 20°-25°C (68°-77°F)
  • alcohol-free
  • packaged with tamper evident seal around cap
  • sodium content 4 mg/5 mL

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

*Robitussin® is a registered trademark of Wyeth Consumer Healthcare.

R11/04

PRINCIPAL 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

DRUG FACTS

Active Ingredient (in each 5 mL teaspoonful)  Purpose

Guaifenesin  100 mg...................................................Expectorant
Dextromethorphan Hydrobromide  10 mg......Cough Suppressant

Uses

  • 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

Warnings

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 accompanies by fever, rash or
persistent headache. 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. In case or overdose, get
medical help or contact a Poison Control Center right away.

Directions

  • do not take more than 6 doses in any
    24-hour period

agedose
adults and children
12 years and over
2 teaspoonfuls
every 4 hours
children 6 years to
under 12 years
1 teaspoonful
every 4 hours
children 2 years to
under 6 years
1/2 teaspoonful
every 4 hours
under 2 yearsask a doctor

Other Information

  • store at 20°-25°C (68°-77°F)
  • alcohol-free
  • packaged with tamper evident seal around cap
  • sodium content 4 mg/5 mL

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

*Robitussin® is a registered trademark of Wyeth Consumer Healthcare.

R08/04

GUAIFENESIN DM 
guaifenesin and dextromethorphan syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0638
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
MENTHOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SACCHARIN SODIUM 
SUCROSE 
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-0638-0010 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
1NDC:0121-0638-055 mL in 1 CUP, UNIT-DOSE
2NDC:0121-0638-04118 mL in 1 BOTTLE
3NDC:0121-0638-08237 mL in 1 BOTTLE
4NDC:0121-0638-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/1992
GUAIFENESIN DM 
guaifenesin and dextromethorphan syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1276
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE 
SODIUM CITRATE 
SACCHARIN SODIUM 
SUCROSE 
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
MENTHOL 
WATER 
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-1276-0010 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
1NDC:0121-1276-1010 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/1992
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Associates, Inc.097630693manufacture(0121-0638, 0121-1276)

 
Pharmaceutical Associates, Inc.

← See all GUAIFENESIN DM brands

Medically reviewed on Mar 21, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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