GUAIFENESIN DM- guaifenesin and dextromethorphan syrup

GUAIFENESIN DM by

Drug Labeling and Warnings

GUAIFENESIN DM by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Associates, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Non-Narcotic, Alcohol Free
Expectorant/Cough Suppressant

DESCRIPTION

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

SPL UNCLASSIFIED SECTION

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).

DOSAGE & ADMINISTRATION

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

HOW SUPPLIED

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 AND HANDLING

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 

• age: dose
• 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 years: ask 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

• age: dose
• 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 years: ask 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

• age: dose
• 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 years: ask 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

INGREDIENTS AND APPEARANCE

GUAIFENESIN DM 
guaifenesin and dextromethorphan syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-0638
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-0638-00	10 in 1 CASE	07/01/1992
1		10 in 1 TRAY
1	NDC: 0121-0638-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 0121-0638-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/1992
3	NDC: 0121-0638-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/1992
4	NDC: 0121-0638-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/1992

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/1992

GUAIFENESIN DM 
guaifenesin and dextromethorphan syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-1276
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCROSE (UNII: C151H8M554)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-1276-00	10 in 1 CASE	07/01/1992
1		10 in 1 TRAY
1	NDC: 0121-1276-10	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/1992

Labeler - Pharmaceutical Associates, Inc. (044940096)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Associates, Inc.		097630693	manufacture(0121-0638, 0121-1276)